Celliant Blood Flow Studies · 2020. 9. 4. · Celliant Blood Flow Studies Objective: To evaluate...

Celliant Blood Flow Studies

Dr. Lawrence A. Lavery, DPM, MPH Loyola Medical University Center

2160 South First Avenue Maywood IL 60153

March 3, 2003

Celliant Blood Flow Studies

Objective: To evaluate changes in peripheral blood flow in the hands and feet of persons

with diabetes when Celliant gloves and stockings are worn. We expect that patients that

wear the Celliant garments will have an increase in local tissue perfusion compared to

baseline and control garments. The study outcomes are transcutaneous oxygen and laser

Doppler flowometry measurements over the course of one hour while the study subjects

wear Celliant garments and placebo garments.

Study Design: This will be a double blind evaluation of changes in peripheral perfusion.

Subjects will act as their own controls. We plan to enroll 20 subjects with a history of

diabetes and vascular impairment. Subjects will be evaluated for baseline blood flow

status. They will then have transcutaneous oxygen (Perimed Inc. North Royalton, Ohio,

PF5040 transcutaneous module) and laser Doppler flowometry measurements

(PF5010Laser Doppler Perfusion module) with stockings and gloves made with and

without Celliant. Measurements will be made prior to wearing the garments and

continuously over a one hour period. We will analyze data at ten minute intervals. The

tester and subject will be blinded to the study garment. Garments will be randomly

selected and tested from a computer generated randomization list. We will take

measurements of both the hand and foot with study subjects wearing Celliant versus

standard fiber gloves and stockings.

The diagnosis of diabetes mellitus will be based on World Health Organization criteria.8

For the purposes of this study, the diagnosis of peripheral vascular disease will be a

transcutaneous oxygen measurement > 30mm Hg taken at the transmetatarsal level on the

day of enrollment. 5, 9

Inclusion Criteria:

1. Diagnosis of Diabetes Mellitus by the World Health Organization Criteria

2. Patient 18 -80 years old.

Exclusion Criteria:

1. Patient currently being treated by dialysis, or having serum creatinine greater than

or equal to 3.0 mg/dl.

2. Patient known to be an active alcohol or substance abuser for the six months prior

to the start of the study.

3. Patient currently receiving systemic corticosteriods in a dose equivalent to greater

than or equal to 10 mg of prednisone per day.

4. Patient currently receiving immunosuppressive agents.

5. Patient currently receiving radiation therapy.

6. Patient currently receiving cytotoxic agents.

7. Patient currently receiving antiviral agents.

8. Patient having history of widespread malignant or systemically

immunocompromising disease.

9. Patient is a female who is breast feeding, pregnant, or attempting to become

pregnant.

10. Patient has other conditions considered by the investigator to be sound reasons

for disqualification (e.g., acute illness or exacerbation of chronic illness, lack of

motivation, and history of poor compliance).

11. Amputation proximal toLisfranc’s(tarsometatarsal) joint or if amputation/surgical

debridement has destroyed the venous plexus of the plantar arch.

12. Acute deep venous thrombosis.

13. Active congestive heart failure.

14. Uncontrolled osteomyelitis.

15. Vascular surgery in the past 4 weeks.

16. Patient has a full thickness skin ulcer.

The dynamic non-invasive vascular assessment will consist of transcutaneous oxygen

pressure (TcPO2) measurement, and laser Doppler flowmetric measurement. We will use

the PeriFlux 5000 System It is a multifunctional system that incorporates four functional

units that combine transcutansous oxygen and laser Doppler function units.

The transcutaneous oxygen electrodes are warmed to 44°C and allowed to equilibrate on

the skin for 5 minutes (until stable values are achieved). The resultant values are

measured in mmHg. 5, 9

The laser Doppler monitor will be used to continuously measure

tissue blood perfusion (PF5010 Laser Doppler Perfusion module). The application is non-

invasive. Two stick-on probes similar to standard EKG probes are applied to the skin. In

the tissue, the laser light is scattered and Doppler shifted by interaction with the moving

blood cells according to the well-known Doppler principle. The sampling depth is on the

order of 200-500 micrometers. A fraction of the backscattered light is detected by a

remotely positioned photo detector.

We will measure transcutaneous oxygen and laser Doppler flowometry measurements

continuously during the one hour evaluation period and record values for 60 seconds at

ten minute intervals on the dorsum of the foot and hand. In addition, we will measure a

two minute interval at the conclusion of each data collection period to compare the

change in blood flow parameters in placebo and Celliant treatment groups.

Results:

We used a paired t-test to compare transcutaneous oxygen (TCOM) and laser Doppler

(LD) values on the hand and foot. Treanscutaneous oxygen measures the partial pressure

of oxygen at the surface of the skin, and the laser Doppler measures capillary blood flow.

As part of the descriptive evaluation of the data we, stratified TCOM and LD into three

levels: increase when comparing Celliant to placebo, no change or a decrease when

comparing Celliant to placebo. If there was less than a 4% change when the placebo vs.

Celliant was used, this was determined to represent “no change”. TCOM’s in the hand

showed 10 subjects with an increase, 4 unchanged and 6 with a decrease when using

Celliant compared to the placebo garment. TCOM’s in the foot again showed 10 subjects

with an increase when using Celliant, 4 were unchanged and 6 were decreased.

There was a statistically significant change in transcutaneous oxygen or the oxygen

delivery to the skin in the hand and foot when using the paired t-test to compare data

collected at time periods 40 and 50 minutes after initiation of testing. The Laser Doppler

studies did not show a difference in blood flow in placebo versus Celliant in either the

hand or the foot. The significant changes observed are very compelling for this type of

product. An 8-12% improvement in skin oxygenation could improve marginal circulation

enough to improve wound healing or eliminate ischemic pain of the legs.

All 10 Minute Interval Data (Paired) Paired T-Test and CI: TCOM HAND-Placebo, TCOM HAND-Celliant Paired T for TCOM HAND-Placebo - TCOM HAND-Celliant N Mean St Dev SE Mean TCOM HAND-Pl 120 15.284 7.613 0.695 TCOM HAND-ho 120 17.323 10.505 0.959 Difference 120 -2.039 7.718 0.705 95% CI for mean difference: (-3.434, -0.644) T-Test of mean difference = 0 (vs not = 0): T-Value = -2.89 P-Value = 0.005

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Histogram of Differences(with Ho and 95% t-confidence interval for the mean)

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All 10 Minute Interval Data (Paired) Paired T-Test and CI: TCOM FOOT-Placebo, TCOM FOOT-Celliant Paired T for TCOM FOOT-Placebo - TCOM FOOT-Celliant N Mean St Dev SE Mean TCOM FOOT-pl 120 52.22 20.39 1.86 TCOM FOOT-ho 120 56.35 20.01 1.83 Difference 120 -4.13 11.25 1.03 95% CI for mean difference: (-6.16, -2.10) T-Test of mean difference = 0 (vs not = 0): T-Value = -4.02 P-Value = 0.000

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All 10 Minute Interval Data (Paired) Paired T-Test and CI: LASER HAND-Placebo, LASER HAND-Celliant Paired T for LASER HAND-Placebo - LASER HAND-Celliant N Mean St Dev SE Mean LASER HAND-p 120 35.00 28.84 2.63 LASER HAND-h 120 33.91 25.62 2.34 Difference 120 1.09 15.67 1.43 95% CI for mean difference: (-1.74, 3.92) T-Test of mean difference = 0 (vs. not = 0): T-Value = 0.76 P-Value = 0.447

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All 10 Minute Interval Data (Paired)

Paired T-Test and CI: LASER FOOT-Placebo, LASER FOOT-Celliant Paired T for LASER FOOT-Placebo - LASER FOOT-Celliant N Mean St Dev SE Mean LASER FOOT-p 120 49.68 21.12 1.93 LASER FOOT-h 120 49.64 19.55 1.78 Difference 120 0.04 15.79 1.44 95% CI for mean difference: (-2.81, 2.90) T-Test of mean difference = 0 (vs. not = 0): T-Value = 0.03 P-Value = 0.976

120100806040200-20-40-60-80

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Last Three Points of 10 Minute Interval Data (Paired)

Paired T-Test and CI: TCOM HAND-Placebo, TCOM HAND-Celliant Paired T for TCOM HAND-Placebo - TCOM HAND-Celliant N Mean St Dev SE Mean TCOM HAND-Pl 60 14.62 7.08 0.91 TCOM HAND-ho 60 17.19 9.75 1.26 Difference 60 -2.572 6.784 0.876 95% CI for mean difference: (-4.325, -0.819) T-Test of mean difference = 0 (vs. not = 0): T-Value = -2.94 P-Value = 0.005

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Last Three Points of 10 Minute Interval Data (Paired)

Paired T-Test and CI: TCOM FOOT-Placebo, TCOM FOOT-Celliant Paired T for TCOM FOOT-Placebo - TCOM FOOT-Celliant N Mean St Dev St Dev SE Mean TCOM FOOT-pl 60 54.19 19.90 2.57 TCOM FOOT-ho 60 58.57 21.29 2.75 Difference 60 -4.38 12.27 1.58 95% CI for mean difference: (-7.55, -1.21) T-Test of mean difference = 0 (vs. not = 0): T-Value = -2.76 P-Value = 0.008

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Last Three Points of 10 Minute Interval Data (Paired) Paired T-Test and CI: LASER HAND-Placebo, LASER HAND-Celliant Paired T for LASER HAND-Placebo - LASER HAND-Celliant N Mean St Dev SE Mean LASER HAND-p 60 33.52 28.32 3.66 LASER HAND-h 60 33.48 25.89 3.34 Difference 60 0.05 15.24 1.97 95% CI for mean difference: (-3.89, 3.98) T-Test of mean difference = 0 (vs. not = 0): T-Value = 0.02 P-Value = 0.981

Paired T-Test and CI: LASER FOOT-Placebo, LASER FOOT-Celliant Paired T for LASER FOOT-Placebo - LASER FOOT-Celliant N Mean St Dev SE Mean LASER FOOT-p 60 49.90 19.48 2.51 LASER FOOT-h 60 51.56 21.49 2.77 Difference 60 -1.65 14.80 1.91 95% CI for mean difference: (-5.48, 2.17) T-Test of mean difference = 0 (vs. not = 0): T-Value = -0.86 P-Value = 0.391

Last Point of 10 Minute Interval Data (Paired) Paired T-Test and CI: TCOM HAND-Placebo, TCOM HAND-Celliant Paired T for TCOM HAND-Placebo - TCOM HAND-Celliant N Mean St Dev SE Mean TCOM HAND-Pl 20 15.15 8.08 1.81 TCOM HAND-ho 20 17.17 10.17 2.28 Difference 20 -2.02 6.60 1.48 95% CI for mean difference: (-5.11, 1.07) T-Test of mean difference = 0 (vs. not = 0): T-Value = -1.37 P-Value = 0.187

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Last Point of 10 Minute Interval Data (Paired) Paired T-Test and CI: TCOM FOOT-Placebo, TCOM FOOT-Celliant Paired T for TCOM FOOT-Placebo - TCOM FOOT-Celliant N Mean S Dev SE Mean TCOM FOOT-pl 20 55.42 20.54 4.59 TCOM FOOT-ho 20 59.48 21.65 4.84 Difference 20 -4.05 11.61 2.60 95% CI for mean difference: (-9.49, 1.38) T-Test of mean difference = 0 (vs. not = 0): T-Value = -1.56 P-Value = 0.135

Paired T-Test and CI: LASER HAND-Placebo, LASER HAND-Celliant Paired T for LASER HAND-Placebo - LASER HAND-Celliant N Mean St Dev SE Mean LASER HAND-p 20 33.87 26.02 5.82 LASER HAND-h 20 33.69 27.39 6.13 Difference 20 0.18 15.89 3.55 95% CI for mean difference: (-7.26, 7.62) T-Test of mean difference = 0 (vs. not = 0): T-Value = 0.05 P-Value = 0.960

Paired T-Test and CI: LASER FOOT-Placebo, LASER FOOT-Celliant Paired T for LASER FOOT-Placebo - LASER FOOT-Celliant N Mean St Dev SE Mean LASER FOOT-p 20 52.52 22.57 5.05 LASER FOOT-h 20 54.97 27.41 6.13 Difference 20 -2.45 24.05 5.38 95% CI for mean difference: (-13.70, 8.80) T-Test of mean difference = 0 (vs. not = 0): T-Value = -0.46 P-Value = 0.654

1st Half to 2nd Half of Test Paired T-Test and CI: 1 Celliant-TCOM Hand, 2 Celliant-TCOM Hand Paired T for 1 Celliant-TCOM Hand - 2 Celliant-TCOM Hand N Mean St Dev SE Mean 1 Celliant-TCOM 60 17.45 11.29 1.46 2 Celliant-TCOM 60 17.19 9.75 1.26 Difference 60 0.256 4.321 0.558 95% CI for mean difference: (-0.860, 1.372) T-Test of mean difference = 0 (vs. not = 0): T-Value = 0.46 P-Value = 0.648

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1st Half to 2nd Half of Test Paired T-Test and CI: 1 Celliant-TCOM Foot, 2 Celliant-TCOM Foot Paired T for 1 Celliant-TCOM Foot - 2 Celliant-TCOM Foot N Mean St Dev SE Mean 1 Celliant-TCOM 60 54.14 18.55 2.39 2 Celliant-TCOM 60 58.57 21.29 2.75 Difference 60 -4.43 9.14 1.18 95% CI for mean difference: (-6.79, -2.07) T-Test of mean difference = 0 (vs. not = 0): T-Value = -3.76 P-Value = 0.000

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1st Half to 2nd Half of Test

Paired T-Test and CI: 1 Placebo-TCOM Hand, 2 Placebo-TCOM Hand Paired T for 1 Placebo-TCOM Hand - 2 Placebo-TCOM Hand N Mean St Dev SE Mean 1 Placebo -TC 60 15.94 8.12 1.05 2 Placebo -TC 60 14.62 7.08 0.91 Difference 60 1.322 5.102 0.659 95% CI for mean difference: (0.004, 2.640) T-Test of mean difference = 0 (vs. not = 0): T-Value = 2.01 P-Value = 0.049

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1st Half to 2nd Half of Test Paired T-Test and CI: 1 Placebo-TCOM Foot, 2 Placebo-TCOM Foot Paired T for 1 Placebo-TCOM Foot - 2 Placebo-TCOM Foot N Mean St Dev SE Mean 1 Placebo-TC 60 50.26 20.85 2.69 2 Placebo-TC 60 54.19 19.90 2.57 Difference 60 -3.930 6.726 0.868 95% CI for mean difference: (-5.668, -2.192) T-Test of mean difference = 0 (vs. not = 0): T-Value = -4.53 P-Value = 0.000

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Last Two Points 10 Minute Interval Data (Paired) Paired T-Test and CI: Placebo-TCOM Hand, Celliant-TCOM Hand Paired T for Placebo-TCOM Hand - Celliant-TCOM Hand N Mean St Dev SE Mean Placebo-TCOM 40 14.68 7.32 1.16 Celliant-TCOM Ha 40 17.49 9.91 1.57 Difference 40 -2.82 6.67 1.05 95% CI for mean difference: (-4.95, -0.68) T-Test of mean difference = 0 (vs. not = 0): T-Value = -2.67 P-Value = 0.011

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Last Two Points 10 Minute Interval Data (Paired) Paired T-Test and CI: Placebo-TCOM Foot, Celliant-TCOM Foot Paired T for Placebo-TCOM Foot - Celliant-TCOM Foot N Mean St Dev SE Mean Placebo-TCOM 40 54.76 19.92 3.15 Celliant-TCOM 40 59.10 21.02 3.32 Difference 40 -4.33 12.85 2.03 95% CI for mean difference: (-8.44, -0.22) T-Test of mean difference = 0 (vs. not = 0): T-Value = -2.13 P-Value = 0.039

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0 10 20 30 40 50 60 70

Time

Placebo-TCOM HandPlacebo-TCOM FootHolo-TCOM HandHolo-TCOM Foot

Limitations: This preliminary study provides some insight into the potential for Celliant.

This project should be considered as a pilot project to build on. Prior to beginning the

project we had little scientific information about the effect that Celliant might have on

perfusion to the extremities. There is obviously a lot that we still do not understand about

Celliant and the best way to optimize its use.

Patient selection: We enrolled diabetic males with an abnormal clinical vascular

examination. Our results may have been better if we included patients with more severe

vascular impairment. The subjects that may benefit the most may be diabetics with very

severe disease, patients with Raynaud’s disease, or peripheral arterial occlusive disease.

For instance, in the future we may want to include patients with baseline transcutaneous

oxygen values less than 20 or 30 mm Hg.

Duration of the evaluation: The study period for this project was one hour. This may

not have been a long enough period to observe the greatest impact of the product. Several

of the patients that have voiced strong subjective improvement related their symptoms

did not change until they wore the garment for more than an hour.

Wash out period: It is unclear if a “wash out” period was needed for subjects that were

treated with the Celliant and subsequently were treated with the placebo garments. This

would suggest that there was a lasting effect of the Celliant material. The current analysis

did not indicate there was a trend to support this theory.

Light Exposure: Since one of the theories regarding the mechanism of action of Celliant

involves infrared light, Celliant may be more effective when the patient is exposed to

natural light during the evaluation period. The current study was conducted in a room

without any exposure to natural light.

Recommendations: The pilot data is compelling. I am very optimistic that we could

pursue additional funding through the National Institute of Health. Probably the best bet

would be to apply for a Technology Transfer Grant or through an award from the

Alternative Medicine Institute of the NIH.

Future research should focus on the target markets for this product. In addition, we

should identify the mechanism of action of Celliant, if that is possible. Initially, I would

build on the data from the current project and focus on vascular improvement and

subjective improvement in persons with diabetes mellitus. My recommendations would

be to expand the scope of the pilot study. We should expand the study population and

evaluate specific “risk groups’ within the diabetic population that would benefit form the

product such as dialysis patients. We need to evaluate patients after they wear Celliant

over the course of hours days or weeks. We should measure vascular parameters as well

as subjective improvement in functional status, sleep habits, and perhaps even glucose

control. A long term, multi-million dollar project would evaluate if Celliant helps to

prevent lower extremity complications such as ulceration, gangrene, and amputation in

high-risk persons with diabetes. This type of outcome would be better than discovering

penicillin.

The athletic market probably has the most potential. There are a number of sports

activities and levels of competition that we could evaluate. In general, we should focus on

measuring improvement in performance in athletes that use Celliant. I would additionally

evaluate subject responses from athletes after using the product, but every shoe company

has a celebrity spokesman that loves the product. I know it is a cliché from the 60’s, but if

we can show that Celliant helps you run faster and jump higher (like PF Flyers) you will

not be able to keep it on the shelf.

Performance outcomes are easy to measure. We can measure changes in speed, jumping,

weight lifting, rowing, cycling or a number of other athletic endeavors. The easiest

approach would be to conduct a classic randomized clinical trial and evaluate two groups

of athletes that use Celliant or placebo garments. We could evaluate military recruits,

high school, college or professional athletes. Another approach would be to use subjects

as their own control and measure pre versus post Celliant athletic performance. We could

relatively easily evaluate if exposure to the product in the course of a few hours,

improves a specific athletic event like weight lifting or the time to run 2 miles.

Funding for these types of projects will be harder to obtain. The NIH’s focus is on

disease states. We would also need pilot data that supports the hypothesis of our athletic

performance research in order to obtain advanced funding.

Is there any evidence that Celliant improves sleep patterns? This could be measured from

subjective patient feedback using a pre – post evaluation of Celliant pajamas and sheets.

A more expensive approach would be to measure sleep patterns in a sleep lab. The

laboratory approach will be more objective and more expensive. Objective data of

enhanced REM sleep and other sleep parameters would attract significant attention to the

product.

There are a number of areas and questions that we could pursue.

1. Does Celliant improve in persons with diabetes?

Does Celliant improve blood flow in diabetics?

Does Celliant improve pain-free walking in diabetic with intermittent claudication?

Does Celliant improve wound healing in venous stasis ulcers, diabetic neuropathic ulcers,

and ischemic ulcers?

Transcutaneous measurement of

the foot mean mean

id no. Order of treatment values values Percentage change Change with

Celliant 121 placebo - Celliant 14.48 27.39 89.07 increase 119 placebo - Celliant 78.74 70.92 -9.93 decrease 118 placebo - Celliant 20.3 43.9 116.3 increase 116 placebo - Celliant 82.35 92.58 12.42 increase 113 placebo - Celliant 45.76 52.44 14.61 increase 112 placebo - Celliant 57.88 60.65 4.79 increase 102 placebo - Celliant 54.65 50.82 -7 decrease 104 placebo - Celliant 65.5 57.96 -11.52 decrease 105 placebo - Celliant 68.51 106.61 55.61 increase 109 placebo - Celliant 91.73 85.74 -6.53 decrease 106 placebo - Celliant 35.79 23.17 -35.25 decrease 107 Celliant - placebo 53.42 37.5 29.8 increase 108 Celliant - placebo 55.63 53.63 3.59 no change 101 Celliant - placebo 54.34 55.82 -2.72 no change 110 Celliant - placebo 92.91 81.88 11.86 increase 111 Celliant - placebo 57.53 48 16.58 increase 114 Celliant - placebo 60.69 62.37 -2.77 no change 115 Celliant - placebo 55.1 57.75 -4.81 decrease 117 Celliant - placebo 44.28 40.93 7.56 increase 120 Celliant - placebo 51.06 51.92 -1.69 no change

Transcutaneous measurment of

the hand mean mean

id no. Order of

treatment values values Percentage

change Change with

Celliant 121 placebo - Celliant 14.82 12.63 -14.81 decrease 119 placebo - Celliant 21.19 31.45 48.4 increase 118 placebo - Celliant 32.5 42.77 31.61 increase 116 placebo - Celliant 5.91 5.98 1.23 no change 113 placebo - Celliant 13.63 14.35 5.34 decrease 112 placebo - Celliant 14.72 15.04 2.18 no change 102 placebo - Celliant 9.51 13.33 40.22 increase 104 placebo - Celliant 11.19 9.95 -11.08 decrease 105 placebo - Celliant 7.28 9.31 27.91 increase 109 placebo - Celliant 11.64 11.95 2.69 no change 106 placebo - Celliant 5.57 7.86 41.18 increase 107 Celliant - placebo 5.64 4.36 22.69 increase 108 Celliant - placebo 16.18 14.6 9.73 increase 101 Celliant - placebo 19.91 14.46 27.36 increase 110 Celliant - placebo 9.56 9.64 -0.89 no change 111 Celliant - placebo 32.73 17.34 47.02 increase 114 Celliant - placebo 22.13 28.45 -28.53 decrease 115 Celliant - placebo 14.58 29.75 -104.02 decrease 117 Celliant - placebo 25.59 12.93 49.47 increase 120 Celliant - placebo 25.81 27.42 -6.27 decrease

Laser doppler of

the hand mean mean

id no. Order of

treatment values values percentage change Change with

Celliant

121 placebo - Celliant 33.81 43.19 27.74 increase

119 placebo - Celliant 84.94 69.28 -18.44 decrease

118 placebo - Celliant 46.02 46.49 1.03 no change







109 placebo - Celliant 15.75 15.22 -3.33 no change

106 placebo - Celliant 6.6 5.5 -16.6 increase

107 Celliant - placebo 12.64 19.07 -50.93 decrease




111 Celliant - placebo 24.55 22.46 8.52 increase

114 Celliant - placebo 105.44 104.88 0.53 no change




Laser doppler of the

foot mean mean

Id no.

Order of treatment values values Percentage change Change with

Celliant








104 placebo - Celliant 65.84 63.16 -4.08 no change








111 Celliant - placebo 31.69 32.89 -3.81 no change


115 Celliant - placebo 58 59.67 -2.87 no change



LITERATURE CITED

1. Most RS, Sinnock P. The epidemiology of lower extremity amputations in diabetic

individuals. Diabetes Care. 1983;6:87-91.

2. Armstrong DG, Lavery LA, Harkless LB. Validation of a diabetic wound

classification system. The contribution of depth, infection, and ischemia to risk of

amputation [see comments]. Diabetes Care. 1998;21:855-9.

3. Lavery LA, Armstrong DG, Vela SA, Quebedeaux TL, Fleischli JG. Practical

Criteria for Screening Patients at High Risk for Diabetic Foot Ulceration. Arch

Intern Med. 1998;158:158-162.

4. LaVan FB, Hunt TK. Oxygen and Wound Healing. Clinics in Plastic Surgery.

1990;17:463-472.

5. Hauser CJ, Klein SR, Mehringer CM, Appel P, Shoemaker WC. Assessment of

perfusion in the diabetic foot by regional transcutaneous oximetry. Diabetes.

1984;33:527-531.

6. Pecoraro RE. Chronology and determinants of Tissue Repair in Diabetic Lower

Extremity Ulcers. Diabetes. 1991;40:1305-1313.

7. Tooke JE. Microcirculation and diabetes. British Medical Bulletin. 1989;45:206-

223.

8. World Health Organization. Second Report on Diabetes Mellitus. . Geneva: World

Health Organization; 1980.

9. Wyss CR, Matsen FA, Simmons CW, Burgess EM. Transcutaneous oxygen tension

measurements on limbs of diabetic and nondiabetic patients with peripheral

vascular disease. Surgery. 1984;95:339-346.

10. Apelqvist J, Castenfors J, Larsson J. Prognostic value of ankle and toe blood

pressure levels in outcome of diabetic foot ulcers. Diabetes Care. 1989;12:373-378.

11. Arnold F, He CYJ, Cherry GW. Perfusion imaging of skin island blood flow by a

scanning laser Doppler device. Brit J Plast Surg. 1995;48:280-287.

12. Kirkwood BR. Essentials of Medical Statistics. . Oxford: Blackwell; 1988.

1. Most RS, Sinnock P. The epidemiology of lower extremity amputations in diabetic

individuals. Diabetes Care. 1983;6:87-91.

2. Armstrong DG, Lavery LA, Harkless LB. Validation of a diabetic wound

classification system. The contribution of depth, infection, and ischemia to risk of

amputation [see comments]. Diabetes Care. 1998;21:855-9.

3. Lavery LA, Armstrong DG, Vela SA, Quebedeaux TL, Fleischli JG. Practical

Criteria for Screening Patients at High Risk for Diabetic Foot Ulceration. Arch

Intern Med. 1998;158:158-162.

4. LaVan FB, Hunt TK. Oxygen and Wound Healing. Clinics in Plastic Surgery.

1990;17:463-472.

5. Hauser CJ, Klein SR, Mehringer CM, Appel P, Shoemaker WC. Assessment of

perfusion in the diabetic foot by regional transcutaneous oximetry. Diabetes.

1984;33:527-531.

6. Pecoraro RE. Chronology and determinants of Tissue Repair in Diabetic Lower

Extremity Ulcers. Diabetes. 1991;40:1305-1313.

7. Tooke JE. Microcirculation and diabetes. British Medical Bulletin. 1989;45:206-

223.

8. World Health Organization. Second Report on Diabetes Mellitus. . Geneva: World

Health Organization; 1980.

9. Wyss CR, Matsen FA, Simmons CW, Burgess EM. Transcutaneous oxygen tension

measurements on limbs of diabetic and nondiabetic patients with peripheral

vascular disease. Surgery. 1984;95:339-346.

10. Apelqvist J, Castenfors J, Larsson J. Prognostic value of ankle and toe blood

pressure levels in outcome of diabetic foot ulcers. Diabetes Care. 1989;12:373-378.

11. Arnold F, He CYJ, Cherry GW. Perfusion imaging of skin island blood flow by a

scanning laser Doppler device. Brit J Plast Surg. 1995;48:280-287.

12. Kirkwood BR. Essentials of Medical Statistics. . Oxford: Blackwell; 1988.

Patient ID: 101 Celliant - placebo

BASELINE TCOM HAND LASER HAND TCOM FOOT LASER FOOT

Mean value (Unit) 24.52 16.82 55.6 49.82 Standard Deviation (Unit) 3.57 6.9 0.48 0.29 Standard Error (Unit) 0.13 0.24 0.02 0.01 Area under curve (Unit*sec.) 1228.34 842.67 2785.16 2495.65 10 MINUTES CELLIANT Mean value (Unit) 19.89 13.29 54.6 44.08 Standard Deviation (Unit) 3.24 3.48 1.36 0.34 Standard Error (Unit) 0.11 0.12 0.05 0.01 Area under curve (Unit*sec.) 994.9 664.9 2731.59 2205.26 20M MINUTES CELLIANT Mean value (Unit) 17.93 12.42 53.86 44.25 Standard Deviation (Unit) 7.33 1.97 1.22 0.87 Standard Error (Unit) 0.26 0.07 0.04 0.03 Area under curve (Unit*sec.) 899.19 622.89 2701.65 2219.58 30 MINUTES CELLIANT Mean value (Unit) 16.01 13.11 55.61 48.34 Standard Deviation (Unit) 3.63 3.99 1.86 0.32 Standard Error (Unit) 0.13 0.14 0.07 0.01 Area under curve (Unit*sec.) 794.3 650.01 2758.62 2397.88 40 MINUTYES CELLIANT Mean value (Unit) 20.84 12.41 50.05 46.7 Standard Deviation (Unit) 4.55 1.68 1.05 0.21 Standard Error (Unit) 0.16 0.06 0.04 0.01 Area under curve (Unit*sec.) 1032.44 615.01 2479.3 2313.27 50 MINUTES CELLIANT Mean value (Unit) 23.19 15.32 51.7 49.39 Standard Deviation (Unit) 3.51 13.77 0.98 0.5 Standard Error (Unit) 0.12 0.48 0.03 0.02 Area under curve (Unit*sec.) 1157.26 764.74 2580.38 2464.88

60 MINUTES CELLIANT TCOM HAND LASER HAND TCOM FOOT LASER FOOT

Mean value (Unit) 18.76 12.15 54.42 46.87 Standard Deviation (Unit) 4.06 1.84 1.52 0.48 Standard Error (Unit) 0.14 0.06 0.05 0.02 Area under curve (Unit*sec.) 948.83 614.15 2752.92 2371.13 10 MINUTES PLACEBO Mean value (Unit) 17.96 16.39 48.23 48.87 Standard Deviation (Unit) 6 4.72 1.01 0.43 Standard Error (Unit) 0.22 0.17 0.04 0.02 Area under curve (Unit*sec.) 876.49 800.13 2353.08 2384.35 20 MINUTES PLACEBO Mean value (Unit) 16.23 14.01 50.2 43.88 Standard Deviation (Unit) 2.58 1.66 1.43 0.55

Standard Error (Unit) 0.09 0.06 0.05 0.02 Area under curve (Unit*sec.) 821.9 709.8 2542.56 2222.42 30 MINUTES PLACEBO Mean value (Unit) 17.15 14.56 56.02 46.79 Standard Deviation (Unit) 2.84 2.43 2.03 0.52 Standard Error (Unit) 0.1 0.09 0.07 0.02 Area under curve (Unit*sec.) 859.03 729.36 2805.87 2343.65 40 MINUTES PLACEBO Mean value (Unit) 16.14 13.25 52.87 45.3 Standard Deviation (Unit) 3.11 2.62 0.59 0.69 Standard Error (Unit) 0.11 0.09 0.02 0.02 Area under curve (Unit*sec.) 809.73 664.6 2651.61 2272.11 50 MINUTES PLACEBO Mean value (Unit) 15.44 14.36 60.51 58.32 Standard Deviation (Unit) 4.63 2.19 0.95 1.29 Standard Error (Unit) 0.17 0.08 0.03 0.05 Area under curve (Unit*sec.) 775.33 721.12 3038.74 2928.89 60 MINUTES PLACEBO Mean value (Unit) 16.08 22.06 55.53 48.87 Standard Deviation (Unit) 7.18 15.94 1.14 2.56 Standard Error (Unit) 0.26 0.57 0.04 0.09 Area under curve (Unit*sec.) 803.07 1100.69 2771.29 2439.26

Patient ID: 102 placebo-Celliant

BASELINE TCOM HAND

LASER HAND

TCOM FOOT

LASER FOOT

Mean value (Unit) 8.66 45.65 55.22 40.67 Standard Deviation (Unit) 2.72 4.5 0.86 0.38 Standard Error (Unit) 0.1 0.16 0.03 0.01 Area under curve (Unit*sec.) 438.71 2312.2 2797.32 2059.9 10 MINUTE PLACEBO Mean value (Unit) 10.27 40.1 5.75 37.56 Standard Deviation (Unit) 3.28 6.94 0.96 0.44 Standard Error (Unit) 0.08 0.17 0.02 0.01 20 MINUTE PLACEBO Mean value (Unit) 10.15 36.71 22.45 40.96 Standard Deviation (Unit) 2.82 6.14 0.62 0.26 Standard Error (Unit) 0.1 0.22 0.02 0.01 Area under curve (Unit*sec.) 501.22 1813.7 1109.29 2023.98 30 MINUTE PLACEBO Mean value (Unit) 10.13 36.2 30.28 41.9 Standard Deviation (Unit) 3.92 3.14 0.83 0.75 Standard Error (Unit) 0.14 0.11 0.03 0.03 Area under curve (Unit*sec.) 514.53 1837.85 1537.66 2127.42 40 MINUTE PLACEBO Mean value (Unit) 11.57 34.57 33.95 47.01 Standard Deviation (Unit) 2.78 3.53 0.35 0.2 Standard Error (Unit) 0.1 0.12 0.01 0.01 Area under curve (Unit*sec.) 593.38 1772.94 1740.97 2410.22 50 MINUTE PLACEBO Mean value (Unit) 9.58 35.59 52.67 47.78 Standard Deviation (Unit) 1.97 3.18 0.1 0.16 Standard Error (Unit) 0.07 0.11 0 0.01 Area under curve (Unit*sec.) 484.85 1800.54 2664.69 2417.03 60 MINUTE PLACEBO Mean value (Unit) 8.99 33.82 55.02 50.6 Standard Deviation (Unit) 2.11 6.96 0.4 0.45 Standard Error (Unit) 0.07 0.24 0.01 0.02 Area under curve (Unit*sec.) 455.18 1712.98 2787.02 2563.31

10 MINUTE CELLIANT TCOM HAND

LASER HAND

TCOM FOOT

LASER FOOT

Mean value (Unit) 8.93 43.3 37.54 59.37 Standard Deviation (Unit) 1.85 3.14 0.27 0.3 Standard Error (Unit) 0.07 0.11 0.01 0.01 Area under curve (Unit*sec.) 444.79 2155.53 1869.08 2955.84

20 MINUTE CELLIANT Mean value (Unit) 9.53 41.92 38.65 57.8 Standard Deviation (Unit) 1.77 2.95 0.13 0.16 Standard Error (Unit) 0.06 0.1 0 0.01 Area under curve (Unit*sec.) 477.24 2099.87 1936.15 2895.57 30 MINUTE CELLIANT Mean value (Unit) 9.67 40.85 40.17 59.47 Standard Deviation (Unit) 1.86 3.69 0.34 0.96 Standard Error (Unit) 0.07 0.13 0.01 0.03 Area under curve (Unit*sec.) 474.01 2003.64 1969.91 2915.9 40 MINUTES CELLIANT Mean value (Unit) 12.06 41.65 40.43 57.87 Standard Deviation (Unit) 2.54 3.65 0.28 0.64 Standard Error (Unit) 0.09 0.13 0.01 0.02 Area under curve (Unit*sec.) 607.67 2099.4 2037.75 2916.84 50 MINUTRE CELLIANT Mean value (Unit) 13.04 43.7 39.8 59.2 Standard Deviation (Unit) 2.62 3.7 0.4 0.15 Standard Error (Unit) 0.09 0.13 0.01 0.01 Area under curve (Unit*sec.) 637.89 2137.86 1946.79 2895.96 60 MINUTES CELLIANT Mean value (Unit) 13.61 46.5 50.5 140.59 Standard Deviation (Unit) 3.61 5.91 1.13 2.51 Standard Error (Unit) 0.11 0.17 0.03 0.07 Area under curve (Unit*sec.) 978.71 3343.47 3630.78 10108.81

Patient ID:104 placebo - Celliant

BASELINE TCOM HAND LASER HAND TCOM FOOT LASER FOOT Mean value (Unit) 9.59 27.27 58.95 74.86 Standard Deviation (Unit) 4.17 5.27 0.52 0.61 Standard Error (Unit) 0.15 0.19 0.02 0.02 Area under curve (Unit*sec.) 467.46 1330.34 2876.43 3652.55 10 MIN PLACEBO Mean value (Unit) 22.31 43.44 65.31 68.88 Standard Deviation (Unit) 10.72 6.89 0.5 0.16 Standard Error (Unit) 0.39 0.25 0.02 0.01 Area under curve (Unit*sec.) 1057.09 2057.66 3093.45 3262.85 20 MIN PLACEBO Mean value (Unit) 19.91 26.3 63.01 64.9 Standard Deviation (Unit) 11.08 7.04 0.65 0.24 Standard Error (Unit) 0.28 0.18 0.02 0.01 Area under curve (Unit*sec.) 1876.28 2478.22 5938.24 6116.34 30 MIN PLACEBO Mean value (Unit) 13.19 28.63 67.04 65 Standard Deviation (Unit) 5.24 5.72 1.51 0.98 Standard Error (Unit) 0.14 0.15 0.04 0.03 Area under curve (Unit*sec.) 1147.35 2489.99 5831.53 5654.23 40 MIN PLACEBO Mean value (Unit) 11.83 29.71 64.06 63.89 Standard Deviation (Unit) 2.87 17.62 1.09 0.84 Standard Error (Unit) 0.07 0.44 0.03 0.02 Area under curve (Unit*sec.) 1200.52 3015.51 6502.62 6485.27 50 MIN PLACEBO Mean value (Unit) 12.13 28.64 66.07 66.32 Standard Deviation (Unit) 6.49 5.6 1.09 0.86 Standard Error (Unit) 0.16 0.14 0.03 0.02 Area under curve (Unit*sec.) 1231.21 2907.27 6706.28 6731.59 60 MIN PLACEBO Mean value (Unit) 11.52 27.4 63.88 63.7 Standard Deviation (Unit) 3.33 4.68 0.7 1.02 Standard Error (Unit) 0.12 0.17 0.02 0.04 Area under curve (Unit*sec.) 563.45 1339.87 3124.95 3116.03 10 MIN CELLIANT Mean value (Unit) 13.06 29.95 59.11 64.74 Standard Deviation (Unit) 6.26 5.17 0.51 2.42 Standard Error (Unit) 0.23 0.19 0.02 0.09 Area under curve (Unit*sec.) 619.53 1420.55 2803.78 3070.87 20 MIN CELLIANT Mean value (Unit) 13.21 28.82 55.27 59.2 Standard Deviation (Unit) 4.51 4.23 0.52 0.59 Standard Error (Unit) 0.16 0.15 0.02 0.02 Area under curve (Unit*sec.) 661.85 1444.08 2768.75 2965.68

30 MIN CELLIANT Mean value (Unit) 13.79 26.41 55.19 61.7 Standard Deviation (Unit) 9.57 6.77 1.25 0.46 Standard Error (Unit) 0.33 0.24 0.04 0.02 Area under curve (Unit*sec.) 699.18 1338.76 2798.95 3129.3 40 MIN CELLIANT Mean value (Unit) 9.03 33.09 63.95 68.85 Standard Deviation (Unit) 2.84 8.03 0.37 0.38 Standard Error (Unit) 0.1 0.28 0.01 0.01 Area under curve (Unit*sec.) 448.06 1642.01 3172.03 3414.72 50 MIN CELLIANT Mean value (Unit) 14.5 31.61 61.32 67.89 Standard Deviation (Unit) 26.64 5.31 0.79 0.52 Standard Error (Unit) 0.94 0.19 0.03 0.02 Area under curve (Unit*sec.) 717.52 1563.87 3034.01 3359.13 60 MIN CELLIANT Mean value (Unit) 8.52 31.54 56.9 64.22 Standard Deviation (Unit) 2.5 5.65 1.04 0.69 Standard Error (Unit) 0.09 0.2 0.04 0.02 Area under curve (Unit*sec.) 427.27 1581.51 2853.88 3221.07

Patient ID:105 placebo - Celliant BASELINE TCOM HAND LASER HAND TCOM FOOT LASER FOOT Mean value (Unit) 6.83 12.06 76.89 57.94 Standard Deviation (Unit) 0.58 1.88 0.27 0.18 Standard Error (Unit) 0.02 0.07 0.01 0.01 Area under curve (Unit*sec.) 349.89 617.69 3937.57 2967.1 10 MIN PLACEBO Mean value (Unit) 8.72 17.24 67.06 52.94 Standard Deviation (Unit) 2.44 1.29 0.17 0.13 Standard Error (Unit) 0.08 0.04 0.01 0 Area under curve (Unit*sec.) 447.72 884.73 3442.6 2717.89 20 MIN PLACEBO Mean value (Unit) 7.63 12.91 69.95 53.39 Standard Deviation (Unit) 0.99 8.66 0.27 0.42 Standard Error (Unit) 0.03 0.3 0.01 0.01 Area under curve (Unit*sec.) 386.29 654.39 3543.14 2704.38 Slope (Unit/sec.) 0.01 -0.11 -0.01 0 30 MIN PLACEBO Mean value (Unit) 7.22 9.8 74.77 62.03 Standard Deviation (Unit) 0.61 1.66 0.18 0.43 Standard Error (Unit) 0.02 0.06 0.01 0.01 Area under curve (Unit*sec.) 369.02 500.96 3824.49 3172.94 40 MIN PLACEBO Mean value (Unit) 7.32 9.89 72.97 60.38 Standard Deviation (Unit) 0.78 1.41 0.43 0.4 Standard Error (Unit) 0.03 0.05 0.01 0.01 Area under curve (Unit*sec.) 374.1 505.5 3727.86 3084.74 50 MIN PLACEBO Mean value (Unit) 7.28 11.94 68.44 57.22 Standard Deviation (Unit) 0.39 1.7 0.35 0.62 Standard Error (Unit) 0.01 0.06 0.01 0.02 Area under curve (Unit*sec.) 372.44 610.92 3500.89 2926.78 60 MIN PLACEBO Mean value (Unit) 7.33 12.98 68.36 57.73 Standard Deviation (Unit) 0.4 1.86 0.21 0.34 Standard Error (Unit) 0.01 0.07 0.01 0.01 Maximum value (Unit) 8.24 18.49 68.79 58.47 Area under curve (Unit*sec.) 360.89 638.56 3364.02 2840.72 10 MIN CELLIANT TCOM HAND LASER HAND TCOM FOOT LASER FOOT Mean value (Unit) 8.39 12.97 67.4 64.54 Standard Deviation (Unit) 0.96 1.22 0.33 0.25 Standard Error (Unit) 0.03 0.04 0.01 0.01 Area under curve (Unit*sec.) 427.72 660.83 3434.87 3289.18 20 MIN HOL0 Mean value (Unit) 8.21 15.47 68.53 63.36 Standard Deviation (Unit) 0.59 2.04 0.09 0.09

Standard Error (Unit) 0.02 0.07 0 0 Area under curve (Unit*sec.) 414.41 780.64 3458.52 3197.45 30 MIN CELLIANT Mean value (Unit) 8.09 13 69.57 61.65 Standard Deviation (Unit) 0.86 1.28 0.09 0.24 Standard Error (Unit) 0.03 0.04 0 0.01 Area under curve (Unit*sec.) 412.29 662.46 3545.72 3141.67 40 MIN CELLIANT Mean value (Unit) 7.94 10.71 100.73 63.74 Standard Deviation (Unit) 0.53 1.04 0.11 0.29 Standard Error (Unit) 0.02 0.04 0 0.01 Minimum value (Unit) 6.68 8.36 100.53 63.05 Area under curve (Unit*sec.) 406.62 548.54 5158.38 3264.19 50 MIN CELLIANT Mean value (Unit) 12.99 14.31 105.67 62.23 Standard Deviation (Unit) 10.5 3.56 0.46 0.27 Standard Error (Unit) 0.36 0.12 0.02 0.01 Area under curve (Unit*sec.) 667.91 735.84 5431.38 3198.7 60 MIN CELLIANT Mean value (Unit) 8.95 10.29 107.61 60.69 Standard Deviation (Unit) 2.4 1.61 0.11 0.18 Standard Error (Unit) 0.08 0.06 0 0.01 Area under curve (Unit*sec.) 456.04 524.2 5484.28 3092.83

Patient ID: 106 placebo - Celliant BASELINE TCOM HAND LASER HAND TCOM FOOT LASER FOOT Mean value (Unit) 4.97 12.13 44.65 55.53 Standard Deviation (Unit) 2.5 7.93 0.5 0.17 Standard Error (Unit) 0.09 0.28 0.02 0.01 Area under curve (Unit*sec.) 250.45 610.53 2248 2795.7 10 MIN PLACEBO Mean value (Unit) 6.72 11.8 33.25 55.67 Standard Deviation (Unit) 5.08 13.08 1.14 0.46 Standard Error (Unit) 0.18 0.46 0.04 0.02 Area under curve (Unit*sec.) 339.01 595.11 1675.82 2806.24 20 MIN PLACEBO Mean value (Unit) 6.56 18.81 33.39 56.16 Standard Deviation (Unit) 3.11 17.69 0.58 0.5 Standard Error (Unit) 0.11 0.62 0.02 0.02 Area under curve (Unit*sec.) 333.41 955.97 1695.63 2851.61 30 MIN PLACEBO Mean value (Unit) 6.58 15.75 31.28 55.92 Standard Deviation (Unit) 2.5 17.71 0.51 0.57 Standard Error (Unit) 0.09 0.62 0.02 0.02 Area under curve (Unit*sec.) 334.68 801 1590.1 2843.11 40 MIN PLACEBO Mean value (Unit) 5.61 9.79 40.6 57.55 Standard Deviation (Unit) 1.19 6.29 1.02 0.32 Standard Error (Unit) 0.04 0.22 0.04 0.01 Area under curve (Unit*sec.) 286.31 499.27 2071.89 2936.59 50 MIN PLACEBO Mean value (Unit) 5.56 11.51 37.27 60.23 Standard Deviation (Unit) 2.11 3.21 0.74 0.5 Standard Error (Unit) 0.07 0.11 0.03 0.02 Area under curve (Unit*sec.) 281.46 581.88 1885.38 3047.07 60 MIN PLACEBO Mean value (Unit) 5.74 11.77 35.16 61.53 Standard Deviation (Unit) 2.03 12.41 0.46 0.57 Standard Error (Unit) 0.07 0.41 0.02 0.02 Area under curve (Unit*sec.) 324.7 665.94 1988.04 3478.76 10 MIN CELLIANT Mean value (Unit) 6.72 16.89 22.6 59.07 Standard Deviation (Unit) 2.81 11.83 0.06 0.32 Standard Error (Unit) 0.1 0.41 0 0.01 Area under curve (Unit*sec.) 342.8 862.07 1153.21 3014.17 20 MIN CELLIANT Mean value (Unit) 8.77 16.54 24.39 60.86 Standard Deviation (Unit) 2.97 7.36 0.22 0.21 Standard Error (Unit) 0.1 0.26 0.01 0.01 Minimum value (Unit) 3.97 6.84 24.11 60.55

Area under curve (Unit*sec.) 444.86 839.7 1238.67 3090.46 30 MIN CELLIANT Item 1 PU #1 2 PU #2 3 pO2 #3 4 pO2 #4 Mean value (Unit) 3.38 12.52 23.67 60.29 Standard Deviation (Unit) 1.68 5.84 0.06 0.42 Standard Error (Unit) 0.06 0.21 0 0.01 Area under curve (Unit*sec.) 167.23 618.67 1169.58 2979.33 40 MIN CELLIANT Mean value (Unit) 5.66 20.19 24.11 61.86 Standard Deviation (Unit) 5.75 11.57 0.1 0.58 Standard Error (Unit) 0.2 0.41 0 0.02 Area under curve (Unit*sec.) 283.09 1011.32 1209.52 3102.92 50 MIN CELLIANT Item 1 PU #1 2 PU #2 3 pO2 #3 4 pO2 #4 Mean value (Unit) 5.75 14.06 23.58 58.75 Standard Deviation (Unit) 3.19 9.45 0.19 0.43 Standard Error (Unit) 0.11 0.33 0.01 0.02 Area under curve (Unit*sec.) 286.12 700.39 1174.03 2925.03 60 MIN CELLIANT Mean value (Unit) 5.89 7.45 23.33 57.99 Standard Deviation (Unit) 2.92 2.55 0.15 0.13 Standard Error (Unit) 0.1 0.09 0.01 0 Area under curve (Unit*sec.) 284.39 359.42 1125.44 2797.23

Patient ID:107 Celliant - placebo BASELINE Item TCOM HAND LASER HAND TCOM FOOT LASER FOOT Mean value (Unit) 3.52 6.05 80.02 63.82 Standard Deviation (Unit) 0.37 0.32 0.35 2.4 Standard Error (Unit) 0.01 0.01 0.01 0.09 Area under curve (Unit*sec.) 170.78 293.47 3879.61 3094.13 10 MIN CELLIANT Mean value (Unit) 4.04 6.07 60.06 52.45 Standard Deviation (Unit) 0.06 0.46 0.1 0.16 Standard Error (Unit) 0 0.02 0 0.01 Area under curve (Unit*sec.) 190.98 286.62 2837.57 2477.93 20 MIN CELLIANT Mean value (Unit) 4.31 6.69 61.73 57.14 Standard Deviation (Unit) 0.19 1.03 0.18 0.17 Standard Error (Unit) 0.01 0.04 0.01 0.01 Area under curve (Unit*sec.) 216.08 335.6 3096.23 2865.82 30 MIN CELLIANT Mean value (Unit) 4.51 5.9 57.26 55.5 Standard Deviation (Unit) 0.15 0.8 0.1 0.22 Standard Error (Unit) 0.01 0.03 0 0.01 Area under curve (Unit*sec.) 227.14 297.47 2886.1 2797.45 40 MIN CELLIANT Mean value (Unit) 4.54 5.84 58.9 55.27 Standard Deviation (Unit) 0.27 1.35 0.11 0.09 Standard Error (Unit) 0.01 0.05 0 0 Area under curve (Unit*sec.) 227.57 292.61 2950.67 2768.95 50 MIN CELLIANT Mean value (Unit) 4.41 4.82 56.98 54.73 Standard Deviation (Unit) 0.15 0.23 0.15 0.2 Standard Error (Unit) 0.01 0.01 0.01 0.01 Minimum value (Unit) 4.27 4.52 56.58 54.32 Area under curve (Unit*sec.) 221.8 242.44 2864.96 2752.06 60 MIN CELLIANT Mean value (Unit) 4.59 6.18 48.35 60.3 Standard Deviation (Unit) 0.37 0.87 0.36 0.31 Standard Error (Unit) 0.01 0.03 0.01 0.01

Area under curve (Unit*sec.) 228.04 306.87 2401.39 2994.84

10 MIN PLACEBO Mean value (Unit) 4.55 6.92 37.97 62.03 Standard Deviation (Unit) 0.31 4.71 0.23 2.04 Standard Error (Unit) 0.01 0.17 0.01 0.07 Area under curve (Unit*sec.) 227.99 347.09 1904.27 3111.28 20 MIN PLACEBO Mean value (Unit) 4.53 5.56 36.89 65.09

Standard Deviation (Unit) 0.52 0.2 0.45 1.24 Standard Error (Unit) 0.02 0.01 0.02 0.04 Area under curve (Unit*sec.) 226.19 277.55 1841.35 3248.56 30 MIN PLACEBO Mean value (Unit) 5.01 4.89 38.65 64.81 Standard Deviation (Unit) 1.49 0.32 0.4 1.65 Standard Error (Unit) 0.05 0.01 0.01 0.06 Area under curve (Unit*sec.) 250.25 244.58 1931.42 3238.84 40 MIN PLACEBO Mean value (Unit) 4.54 5.83 37.83 62.23 Standard Deviation (Unit) 0.5 0.93 0.04 0.36 Standard Error (Unit) 0.02 0.03 0 0.01 Area under curve (Unit*sec.) 228.01 292.78 1899.64 3125.22 50 MIN PLACEBO Mean value (Unit) 4.57 7.16 37.71 62.6 Standard Deviation (Unit) 0.32 2.74 0.07 1.08 Standard Error (Unit) 0.01 0.1 0 0.04 Area under curve (Unit*sec.) 226.17 354.81 1868.13 3100.91 60 MIN PLACEBO Mean value (Unit) 4.51 5.44 37.1 63.37 Standard Deviation (Unit) 0.34 0.28 0.15 0.77 Standard Error (Unit) 0.01 0.01 0.01 0.03 Area under curve (Unit*sec.) 226.15 272.75 1860.74 3178.5

Patient ID:108 Celliant - placebo BASELINE TCOM HAND LASER HAND TCOM FOOT LASER FOOT Mean value (Unit) 10.99 12.62 64.67 65.36 Standard Deviation (Unit) 1.58 8.11 0.54 0.33 Standard Error (Unit) 0.06 0.28 0.02 0.01 Area under curve (Unit*sec.) 557.28 640.06 3279.66 3315.06 Duration (sec.) 50.78 50.78 50.78 50.78 10 min CELLIANT Mean value (Unit) 19.38 14.83 51.17 51.83 Standard Deviation (Unit) 2.02 6.5 0.93 1.97 Standard Error (Unit) 0.07 0.23 0.03 0.07

Area under curve (Unit*sec.) 976.89 747.25 2579.49 2612.72 20 MIN CELLIANT Mean value (Unit) 17.08 11.45 49.79 50.6 Standard Deviation (Unit) 1.6 1.84 0.26 0.28 Standard Error (Unit) 0.06 0.06 0.01 0.01 Area under curve (Unit*sec.) 860.7 577.1 2509.51 2550.36 30 MIN CELLIANT Mean value (Unit) 16.32 12.18 49.5 48.66 Standard Deviation (Unit) 1.83 4.92 0.18 0.29 Standard Error (Unit) 0.06 0.17 0.01 0.01 Area under curve (Unit*sec.) 829.66 618.74 2516.66 2473.87 40 MIN CELLIANT Mean value (Unit) 17.07 12.71 53.03 50.48 Standard Deviation (Unit) 1.82 7.25 0.75 0.65 Standard Error (Unit) 0.05 0.21 0.02 0.02 Area under curve (Unit*sec.) 1212.43 902.93 3767.74 3586.89 50 MIN CELLIANT 6 Mean value (Unit) 16.77 19.04 52.31 51.16 Standard Deviation (Unit) 2.71 10.84 0.35 0.5 Standard Error (Unit) 0.09 0.38 0.01 0.02 Area under curve (Unit*sec.) 854.54 970.53 2665.87 2607.19 60 MIN CELLIANT Mean value (Unit) 15.99 12.58 55.56 57.65 Standard Deviation (Unit) 1.62 1.9 0.33 0.22 Standard Error (Unit) 0.06 0.07 0.01 0.01 Area under curve (Unit*sec.) 809.26 636.3 2810.94 2916.88 10 MIN PLACEBO Mean value (Unit) 12.9 14.1 52.2 164 Standard Deviation (Unit) 1.9 3.18 0.28 7.88 Standard Error (Unit) 0.07 0.11 0.01 0.28 Area under curve (Unit*sec.) 644.7 704.93 2608.34 8197.44 20 MIN PLACEBO Mean value (Unit) 13.6 16.22 51.1 43.19 Standard Deviation (Unit) 4 7.43 0.36 0.47 Standard Error (Unit) 0.14 0.26 0.01 0.02

Area under curve (Unit*sec.) 674.31 804.35 2534.63 2142.27 30 MIN PLACEBO Mean value (Unit) 13.69 14.34 51.85 44.83 Standard Deviation (Unit) 2.96 4.03 0.12 0.22 Standard Error (Unit) 0.1 0.14 0 0.01 Area under curve (Unit*sec.) 684.38 716.98 2591.1 2240.1 40 MIN PLACEBO Mean value (Unit) 12.48 15.28 51.48 44.11 Standard Deviation (Unit) 1.86 5.77 0.36 0.51 Standard Error (Unit) 0.07 0.2 0.01 0.02 Area under curve (Unit*sec.) 622.25 761.74 2565.95 2198.53 50 MIN PLACEBO Mean value (Unit) 13.56 16.21 52.09 41.92 Standard Deviation (Unit) 3.79 5.05 0.15 0.26 Standard Error (Unit) 0.13 0.18 0.01 0.01 Area under curve (Unit*sec.) 681.12 814.34 2615.75 2105.18 60 MIN PLACEBO Mean value (Unit) 13.9 15.36 54.05 107.15 Standard Deviation (Unit) 2.87 5.2 0.23 8.2 Standard Error (Unit) 0.1 0.18 0.01 0.29 Area under curve (Unit*sec.) 692.65 765.29 2692.18 5337.14


BASELINE TCOM HAND LASER HAND TCOM FOOT LASER FOOT Mean value (Unit) 12.37 17.97 69.93 22.66 Standard Deviation (Unit) 1.33 3.93 0.33 1.09 Standard Error (Unit) 0.05 0.14 0.01 0.04 Area under curve (Unit*sec.) 627.48 910.86 3546.44 1149.41 10 MIN PLACEBO Mean value (Unit) 10.94 16.36 80.45 39.43 Standard Deviation (Unit) 1.31 4.65 0.42 0.43 Standard Error (Unit) 0.05 0.16 0.02 0.02 Area under curve (Unit*sec.) 542.22 810.41 3985.22 1953.28 Slope (Unit/sec.) 0.02 0.01 -0.01 0.02 20 MIN PLACEBO 3 Mean value (Unit) 11.01 18.53 78.56 39.61 Standard Deviation (Unit) 1.2 2.43 0.51 0.74 Standard Error (Unit) 0.04 0.09 0.02 0.03 Area under curve (Unit*sec.) 543.17 914.79 3877.33 1954.83 30 MIN PLACEBO Mean value (Unit) 11.41 20.12 78.08 39.34 Standard Deviation (Unit) 1.05 2.77 0.56 0.67 Standard Error (Unit) 0.04 0.1 0.02 0.02 Area under curve (Unit*sec.) 559.43 986.78 3829.11 1929.46 40 MIN PLACEBO Mean value (Unit) 11.25 18.91 86.07 45.31 Standard Deviation (Unit) 1.01 3.88 0.46 0.39 Standard Error (Unit) 0.03 0.1 0.01 0.01 Area under curve (Unit*sec.) 980.23 1648.17 7501.65 3949.1 50 MIN PLACEBO Mean value (Unit) 11.31 16.76 90.1 48.17 Standard Deviation (Unit) 1.19 2.06 1.21 0.53 Standard Error (Unit) 0.03 0.06 0.03 0.01 Area under curve (Unit*sec.) 923.86 1369.05 7361.88 3935.63 60 MIN PLACEBO Mean value (Unit) 12.13 20.15 90.4 48.59 Standard Deviation (Unit) 1.21 2.28 0.63 0.44 Standard Error (Unit) 0.04 0.08 0.02 0.02 Area under curve (Unit*sec.) 613.82 1019.33 4573.49 2458.45 10 MIN CELLIANT Mean value (Unit) 11.92 14.63 80.47 40.44 Standard Deviation (Unit) 1.42 1.9 2.72 1.24 Standard Error (Unit) 0.05 0.07 0.1 0.04 Area under curve (Unit*sec.) 599.46 735.61 4046.39 2033.34 20 MIN CELLIANT Mean value (Unit) 11.88 13.37 72.12 38.02 Standard Deviation (Unit) 0.95 2.01 0.58 0.57 Standard Error (Unit) 0.03 0.07 0.02 0.02

Area under curve (Unit*sec.) 602.5 677.87 3657.6 1928.26

30 MIN CELLIANT Mean value (Unit) 11.77 16.7 76.19 42.17 Standard Deviation (Unit) 1.27 2.06 0.99 1.12 Standard Error (Unit) 0.04 0.07 0.03 0.04 Area under curve (Unit*sec.) 592.39 841.03 3835.59 2122.75 40 MIN CELLIANT Mean value (Unit) 12.15 11.44 83.75 47.17 Standard Deviation (Unit) 1 0.92 0.68 0.64 Standard Error (Unit) 0.04 0.03 0.02 0.02 Area under curve (Unit*sec.) 609.21 573.86 4200.81 2365.71 50 MIN CELLIANT Mean value (Unit) 12.43 18.18 76.08 44.63 Standard Deviation (Unit) 1.38 1.67 0.36 0.25 Standard Error (Unit) 0.05 0.06 0.01 0.01 Area under curve (Unit*sec.) 614.44 898.5 3759.35 2205.23 60 MIN CELLIANT Mean value (Unit) 11.87 13.32 88.75 53.17 Standard Deviation (Unit) 1.91 1.82 1.58 0.67 Standard Error (Unit) 0.07 0.06 0.06 0.02 Area under curve (Unit*sec.) 592.94 665.79 4435.1 2657.24

Patient ID:110 Celliant - placebo


Mean value (Unit) 6.29 12.12 64.93 52.82 Standard Deviation (Unit) 0.57 1.56 0.77 0.24 Standard Error (Unit) 0.02 0.05 0.03 0.01 Maximum value (Unit) 7.48 15.66 66.35 53.28 Minimum value (Unit) 5.13 8.06 63.78 52.55 Area under curve (Unit*sec.) 321.5 619.35 3317.14 2698.66 Slope (Unit/sec.) 0 0.03 -0.05 -0.02 10 MIN CELLIANT Mean value (Unit) 8.38 14.3 90.03 43.66 Standard Deviation (Unit) 0.7 2.06 0.25 0.12 Standard Error (Unit) 0.02 0.07 0.01 0 Area under curve (Unit*sec.) 428.97 732.38 4610.73 2235.98 20 MIN CELLIANT Mean value (Unit) 8.69 14.92 100.01 43.02 Standard Deviation (Unit) 0.98 2.13 0.31 0.12 Standard Error (Unit) 0.03 0.07 0.01 0 Area under curve (Unit*sec.) 440.17 755.67 5065.99 2178.95 30 MIN CELLIANT Mean value (Unit) 9.12 15.77 84.96 41.59 Standard Deviation (Unit) 0.59 2.17 0.6 0.13 Standard Error (Unit) 0.02 0.08 0.02 0 Area under curve (Unit*sec.) 466.04 805.7 4340.29 2124.97 40 MIN CELLIANT Mean value (Unit) 9.36 15.97 89.88 40.61 Standard Deviation (Unit) 0.71 2.96 0.81 0.12 Standard Error (Unit) 0.02 0.1 0.03 0 Area under curve (Unit*sec.) 471.94 805.31 4530.55 2047.06 50 MIN CELLIANT Mean value (Unit) 9.33 15.41 89.14 40.4 Standard Deviation (Unit) 0.72 2.58 0.83 0.17 Standard Error (Unit) 0.02 0.09 0.03 0.01 Area under curve (Unit*sec.) 475.87 786.19 4548.24 2061.61 60 MIN CELLIANT Mean value (Unit) 9.45 14.8 92.8 40.26 Standard Deviation (Unit) 0.53 2.42 0.26 0.03 Standard Error (Unit) 0.02 0.09 0.01 0 Area under curve (Unit*sec.) 455.86 713.73 4476.48 1942.11 10 MIN PLACEBO Mean value (Unit) 8.16 15.96 78.26 48.44 Standard Deviation (Unit) 0.72 2.4 1.72 0.74 Standard Error (Unit) 0.03 0.08 0.06 0.03 Area under curve (Unit*sec.) 414.14 810.73 3974.03 2459.69 20 MIN PLACEBO Mean value (Unit) 8.49 17.29 83.83 47.58

Standard Deviation (Unit) 0.85 2.65 2.09 0.88 Standard Error (Unit) 0.03 0.09 0.07 0.03 Area under curve (Unit*sec.) 430.46 877.06 4251.55 2412.81 30 MIN PLACEBO Mean value (Unit) 8.56 18.64 83.54 46.22 Standard Deviation (Unit) 0.97 3.92 0.28 0.14 Standard Error (Unit) 0.03 0.14 0.01 0.01 Area under curve (Unit*sec.) 431.51 939.79 4211.12 2329.88 40 MIN PLACEBO Mean value (Unit) 8.96 17.94 79.84 42.63 Standard Deviation (Unit) 0.95 2.99 0.65 0.28 Standard Error (Unit) 0.03 0.1 0.02 0.01 Area under curve (Unit*sec.) 456.31 913.03 4064.21 2169.69 50 MIN PLACEBO Mean value (Unit) 9.16 20.65 83.29 44.54 Standard Deviation (Unit) 1.04 4.5 0.5 0.08 Standard Error (Unit) 0.04 0.16 0.02 0 Area under curve (Unit*sec.) 465.88 1050.09 4234.54 2264.57 60 MIN PLACEBO Mean value (Unit) 9.99 22.16 91.47 48.61 Standard Deviation (Unit) 1.57 6.96 1.86 1.09 Standard Error (Unit) 0.04 0.18 0.05 0.03 Area under curve (Unit*sec.) 897.12 1989.09 8211.3 4363.73



Mean value (Unit) 33.49 8.71 57.58 68.57 Standard Deviation (Unit) 6.41 2.61 1.93 3.38 Standard Error (Unit) 0.09 0.04 0.03 0.05 Maximum value (Unit) 71.81 42.51 61.22 77.76 Minimum value (Unit) 17.27 5.07 54.87 63.23 Area under curve (Unit*sec.) 10328.53 2684.65 17756.92 21146.53 Slope (Unit/sec.) 0.01 0.01 0.02 0.03 10 MIN CELLIANT Mean value (Unit) 25.68 10.68 61.46 28.98 Standard Deviation (Unit) 3.14 2.6 1.09 0.41 Standard Error (Unit) 0.06 0.05 0.02 0.01 Area under curve (Unit*sec.) 4869.38 2025.36 11652.76 5495.14 20 MIN CELLIANT Mean value (Unit) 30.11 10.61 59.18 28.57 Standard Deviation (Unit) 4.43 2.14 2.06 1.44 Standard Error (Unit) 0.09 0.04 0.04 0.03 Area under curve (Unit*sec.) 5050.32 1780.16 9925.2 4791.03 30 MIN CELLIANT Mean value (Unit) 28.25 9.94 58.3 29.19 Standard Deviation (Unit) 4.34 1.65 2.66 2.33 Standard Error (Unit) 0.08 0.03 0.05 0.04 Area under curve (Unit*sec.) 4738.63 1666.57 9777.08 4895.74 40 MIN CELLIANT Mean value (Unit) 26.16 11.55 61.93 33.59 Standard Deviation (Unit) 2.94 2.21 2.88 2.44 Standard Error (Unit) 0.06 0.04 0.06 0.05 Area under curve (Unit*sec.) 4195.76 1853.45 9934.88 5389.17 50 MIN CELLIANT Mean value (Unit) 31.71 12.47 60.23 32.63 Standard Deviation (Unit) 2.81 2.27 0.92 0.75 Standard Error (Unit) 0.06 0.05 0.02 0.02 Area under curve (Unit*sec.) 4855.39 1909.35 9221.95 4997.09 60 MIN CELLIANT Mean value (Unit) 32.53 12.07 57.38 31.65 Standard Deviation (Unit) 3.11 2.27 0.52 0.71 Standard Error (Unit) 0.07 0.05 0.01 0.02 Area under curve (Unit*sec.) 4271.81 1585.26 7534.79 4155.52 10 MIN PLACEBO Mean value (Unit) 13.34 22 50.03 31.34 Standard Deviation (Unit) 2.72 4.44 0.91 0.78

Standard Error (Unit) 0.05 0.08 0.02 0.01 Area under curve (Unit*sec.) 2629.01 4337.03 9861.82 6176.8 20 MIN PLACEBO Mean value (Unit) 15.35 18.41 50.46 31.39 Standard Deviation (Unit) 4.78 3 0.62 0.64 Standard Error (Unit) 0.09 0.06 0.01 0.01 Area under curve (Unit*sec.) 2689.27 3225.25 8840.61 5499.54 30 MIN PLACEBO Mean value (Unit) 14.99 15.01 51.53 32.62 Standard Deviation (Unit) 1.89 2.93 0.71 0.7 Standard Error (Unit) 0.03 0.05 0.01 0.01 Area under curve (Unit*sec.) 2954.92 2958.87 10157.22 6430.27 40 MIN PLACEBO Mean value (Unit) 17.76 11.82 51.37 32.11 Standard Deviation (Unit) 5.01 2.05 0.69 0.68 Standard Error (Unit) 0.09 0.04 0.01 0.01 Area under curve (Unit*sec.) 3241.05 2157.53 9375.34 5860.34 50 MIN PLACEBO Mean value (Unit) 16.83 16.81 51.45 33.53 Standard Deviation (Unit) 1.75 4.54 1.03 0.7 Standard Error (Unit) 0.03 0.08 0.02 0.01 Area under curve (Unit*sec.) 3808.88 3805.03 11644.76 7589.4 60 MIN PLACEBO 17.34 16.89 47.43 32.54 Standard Deviation (Unit) 1.34 2.78 0.91 0.58 Standard Error (Unit) 0.02 0.05 0.02 0.01 Area under curve (Unit*sec.) 3545.38 3452.11 9695.11 6652.54

Patient ID: 112 placebo - Celliant BASELINE TCOM HAND LASER HAND TCOM FOOT LASER FOOT Mean value (Unit) 16.01 40.53 57.54 61.8 Standard Deviation (Unit) 2.99 13.56 0.35 0.51 Standard Error (Unit) 0.11 0.48 0.01 0.02 Area under curve (Unit*sec.) 795.15 2012.84 2857.73 3069 Slope (Unit/sec.) 0.08 0.76 0.02 0.03 10 MIN PLACEBO Mean value (Unit) 19.81 65.83 54.54 62.38 Standard Deviation (Unit) 6.77 7.89 0.6 0.68 Standard Error (Unit) 0.24 0.28 0.02 0.02 Area under curve (Unit*sec.) 992.65 3298.75 2732.23 3125.17 Slope (Unit/sec.) 0 -0.03 -0.04 -0.05 20 MIN PLACEBO Mean value (Unit) 14.44 49.46 55.21 63.29 Standard Deviation (Unit) 3.32 18.21 0.07 0.09 Standard Error (Unit) 0.12 0.65 0 0 Area under curve (Unit*sec.) 712.62 2441.15 2724.49 3123.51 30 MIN PLACEBO Mean value (Unit) 11.53 39.22 57.25 64.08 Standard Deviation (Unit) 0.75 6.95 0 0.04 Standard Error (Unit) 0.03 0.24 0 0 Area under curve (Unit*sec.) 577.31 1964.84 2868.05 3210.11 40 MIN PLACEBO Mean value (Unit) 14.72 36.98 56.43 62.96 Standard Deviation (Unit) 3.19 4.27 0.08 0.07 Standard Error (Unit) 0.11 0.15 0 0 Area under curve (Unit*sec.) 744.55 1871.41 2854.91 3185.09 50 MIN PLACEBO Mean value (Unit) 13.29 16.18 56.11 62.44 Standard Deviation (Unit) 2.71 9.12 0.15 0.2 Standard Error (Unit) 0.1 0.32 0.01 0.01 Area under curve (Unit*sec.) 670.14 815.61 2828.5 3147.15 60 MIN PLACEBO Mean value (Unit) 14.82 24.93 57.97 62.27 Standard Deviation (Unit) 4.36 2.89 0.61 0.14 Standard Error (Unit) 0.15 0.1 0.02 0 Area under curve (Unit*sec.) 750.88 1262.79 2936.45 3154.07 10 MIN CELLIANT Mean value (Unit) 13.27 37.71 63 67.08 Standard Deviation (Unit) 2.12 5.25 0.26 0.27 Standard Error (Unit) 0.07 0.19 0.01 0.01 Area under curve (Unit*sec.) 658.29 1870.75 3125.01 3327.29 20 MIN CELLIANT Mean value (Unit) 15.16 29.61 59.56 64.89 Standard Deviation (Unit) 3.71 7.88 0.04 0.13

Standard Error (Unit) 0.13 0.28 0 0 Area under curve (Unit*sec.) 759.79 1484.62 2983.51 3250.59 30 MIN CELLIANT Mean value (Unit) 15.61 24.5 60.51 65 Standard Deviation (Unit) 2.6 4.56 0.75 0.51 Standard Error (Unit) 0.09 0.16 0.03 0.02 Area under curve (Unit*sec.) 781.98 1227.67 3031.34 3256.38 40 MIN CELLIANT Mean value (Unit) 13.91 28.46 60.96 65.65 Standard Deviation (Unit) 3 5.51 0.19 0.19 Standard Error (Unit) 0.11 0.19 0.01 0.01 50 MIN CELLIANT Mean value (Unit) 17.37 27.45 63.52 67.55 Standard Deviation (Unit) 6.72 4.78 1.02 0.72 Standard Error (Unit) 0.24 0.17 0.04 0.03 Area under curve (Unit*sec.) 871.64 1377.42 3186.25 3388.11 60 MIN CELLIANT Mean value (Unit) 14.3 28.04 60.31 64.34 Standard Deviation (Unit) 2.5 5.69 0.08 0.11 Standard Error (Unit) 0.09 0.2 0 0 Area under curve (Unit*sec.) 718.24 1408.51 3029.02 3231.07

Patient ID: 113 placebo - Celliant BASELINE TCOM HAND LASER HAND TCOM FOOT LASER FOOT Mean value (Unit) 11.73 37.11 44.18 53.16 Standard Deviation (Unit) 0.6 14.89 0.26 0.23 Standard Error (Unit) 0.02 0.6 0.01 0.01 Area under curve (Unit*sec.) 443.53 1405.21 1670.88 2010.66 10 MIN PLACEBO Mean value (Unit) 13.38 11.77 37.79 49.16 Standard Deviation (Unit) 0.98 3.31 0.62 0.86 Standard Error (Unit) 0.04 0.13 0.03 0.03 20M MIN PLACEBO Mean value (Unit) 12.79 31.57 36.21 47.2 Standard Deviation (Unit) 0.76 30.34 0.29 0.1 Standard Error (Unit) 0.03 1.25 0.01 0 Area under curve (Unit*sec.) 464.56 1147.38 1315.59 1714.9 30 MIN PLACEBO Mean value (Unit) 13.68 10.83 42.7 49.34 Standard Deviation (Unit) 1.25 4.02 0.09 0.16 Standard Error (Unit) 0.05 0.16 0 0.01 Area under curve (Unit*sec.) 522.46 413.97 1630.78 1884.25 40 MIN PLACEBO Mean value (Unit) 13.56 23.89 41.05 46.79 Standard Deviation (Unit) 0.94 32.39 0.4 0.5 Standard Error (Unit) 0.04 1.31 0.02 0.02 Area under curve (Unit*sec.) 514.29 907.18 1557.78 1775.61 50 MIN PLACEBO Mean value (Unit) 13.11 11.39 44.02 47.54 Standard Deviation (Unit) 0.66 8.92 0.34 0.22 Standard Error (Unit) 0.03 0.36 0.01 0.01 Area under curve (Unit*sec.) 502.26 436.37 1686.68 1821.62 60 MIN PLACEBO Mean value (Unit) 13.22 26.59 45.05 49.64 Standard Deviation (Unit) 1.47 17.24 0.15 0.21 Standard Error (Unit) 0.06 0.7 0.01 0.01 Area under curve (Unit*sec.) 502.46 1011.3 1712.09 1886.64 10 MIN CELLIANT Mean value (Unit) 15.03 15.44 42.68 44.94 Standard Deviation (Unit) 1.05 5.91 0.19 0.59 Standard Error (Unit) 0.04 0.24 0.01 0.02 Area under curve (Unit*sec.) 559.9 575.51 1590.17 1674.57 20 MIN CELLIANT

Mean value (Unit) 14.3 26.8 46.36 49.38 Standard Deviation (Unit) 3.32 44.74 0.09 0.59 Standard Error (Unit) 0.13 1.81 0 0.02 Area under curve (Unit*sec.) 539.98 1010.99 1750.52 1864.47 30 MIN CELLIANT Mean value (Unit) 14.98 17.83 49.69 60.29 Standard Deviation (Unit) 1.81 7.41 1 0.66 Standard Error (Unit) 0.07 0.3 0.04 0.03 Area under curve (Unit*sec.) 565.73 673.1 1876.23 2276.41 40 MIN CELLIANT Mean value (Unit) 14.24 13.77 53.91 59.06 Standard Deviation (Unit) 1.67 13.84 0.14 2.54 Standard Error (Unit) 0.07 0.56 0.01 0.1 Area under curve (Unit*sec.) 536.5 519.01 2032.21 2226.07 50 MIN CELLIANT Mean value (Unit) 15.09 19.44 55.61 61.52 Standard Deviation (Unit) 2.35 14.84 0.29 0.18 Standard Error (Unit) 0.1 0.6 0.01 0.01 Area under curve (Unit*sec.) 570.79 735.48 2103.19 2326.66 60 MIN CELLIANT Mean value (Unit) 14.49 12.54 52.19 52.64 Standard Deviation (Unit) 1.29 3.37 0.44 0.6 Standard Error (Unit) 0.05 0.14 0.02 0.02 Area under curve (Unit*sec.) 551.5 476.94 1986.72 2003.69

Patient ID: 114 Celliant - placebo BASELINE TCOM HAND LASER HAND TCOM FOOT LASER FOOT Mean value (Unit) 16.16 29.8 53.82 26.28 Standard Deviation (Unit) 1.21 5.2 0.88 0.25 Standard Error (Unit) 0.05 0.22 0.04 0.01 Area under curve (Unit*sec.) 569.29 1049.13 1895.28 925.65 10 MIN CELLIANT Mean value (Unit) 28.72 47.2 49.62 48.58 Standard Deviation (Unit) 1.08 30.98 0.23 0.3 Standard Error (Unit) 0.04 1.26 0.01 0.01 Area under curve (Unit*sec.) 1066.78 1753.81 1842.96 1804.27 20 MIN CELLIANT Mean value (Unit) 23.56 21.1 53.96 49.08 Standard Deviation (Unit) 1.88 8.68 0.38 0.23 Standard Error (Unit) 0.08 0.35 0.02 0.01 Area under curve (Unit*sec.) 885.25 792.98 2027.29 1844.15 30 MIN CELLIANT Mean value (Unit) 24.46 23.72 53.66 51.29 Standard Deviation (Unit) 5.94 3.84 0.21 0.12 Standard Error (Unit) 0.28 0.18 0.01 0.01 Area under curve (Unit*sec.) 684.21 663.36 1500.47 1434.21 40 MIN CELLIANT Mean value (Unit) 22.82 25.35 55.94 52.34 Standard Deviation (Unit) 1.23 4.94 0.12 0.12 Standard Error (Unit) 0.06 0.22 0.01 0.01 Area under curve (Unit*sec.) 697.48 774.94 1709.74 1599.74 50 MIN CELLIANT Mean value (Unit) 23.18 22.17 58.83 55.01 Standard Deviation (Unit) 1.78 2.96 1.58 0.46 Standard Error (Unit) 0.07 0.12 0.06 0.02 Area under curve (Unit*sec.) 865.23 827.2 2195.65 2053.21 60 MIN CELLIANT Mean value (Unit) 23.22 34.93 61.01 59.54 Standard Deviation (Unit) 1.79 36.16 0.4 0.19 Standard Error (Unit) 0.07 1.47 0.02 0.01 Area under curve (Unit*sec.) 865.21 1302.78 2273.16 2218.5 10 MIN PLACEBO Mean value (Unit) 25.53 18.31 57.44 61.32 Standard Deviation (Unit) 2 2.59 0.56 0.69 Standard Error (Unit) 0.08 0.11 0.02 0.03 Area under curve (Unit*sec.) 925.79 664.25 2083.34 2223.99 20 MIN PLACEBO Mean value (Unit) 23.72 23.8 58.36 63.01 Standard Deviation (Unit) 1.47 3.55 0.06 0.13 Standard Error (Unit) 0.06 0.15 0 0.01 Area under curve (Unit*sec.) 776.45 778.68 1910.64 2062.73

Slope (Unit/sec.) 0.04 0.04 0 0.01 30M MIN PLACEBO Mean value (Unit) 23.61 22.49 59.07 61.56 Standard Deviation (Unit) 1.49 4.2 0.41 0.16 Standard Error (Unit) 0.06 0.18 0.02 0.01 Area under curve (Unit*sec.) 834.35 794.72 2087.6 2175.4 40 MIN PLACEBO Mean value (Unit) 27.04 22.16 64.38 65.88 Standard Deviation (Unit) 2.05 3.85 0.67 0.18 Standard Error (Unit) 0.08 0.16 0.03 0.01 Area under curve (Unit*sec.) 1009.22 826.95 2402.88 2459.07 50 MIN PLACEBO Mean value (Unit) 26.4 25.38 61.35 62.59 Standard Deviation (Unit) 1.85 6.67 0.14 0.09 Standard Error (Unit) 0.08 0.28 0.01 0 Area under curve (Unit*sec.) 959.01 922.03 2228.99 2273.99 60 MIN PLACEBO Mean value (Unit) 28 22.28 62.41 60.32 Standard Deviation (Unit) 1.61 2.87 0.58 0.11 Standard Error (Unit) 0.07 0.12 0.02 0 Area under curve (Unit*sec.) 973.76 775.08 2170.64 2098.21



Mean value (Unit) 8.01 74 59.65 61.72 Standard Deviation (Unit) 1.56 7.98 0.33 0.52 Standard Error (Unit) 0.07 0.34 0.01 0.02 Area under curve (Unit*sec.) 273.12 2523.81 2034.05 2104.71 10 MIN CELLIANT Mean value (Unit) 8.98 97.65 50.25 52.22 Standard Deviation (Unit) 1.26 7.4 0.17 0.13 Standard Error (Unit) 0.04 0.26 0.01 0 Area under curve (Unit*sec.) 457.48 4976.38 2560.96 2661.17 20 MIN CELLIANT Mean value (Unit) 9.42 96.64 49.54 51.55 Standard Deviation (Unit) 1.21 6.74 0.05 0.1 Standard Error (Unit) 0.05 0.26 0 0 Area under curve (Unit*sec.) 402.27 4128.6 2116.07 2202.22 30 MIN CELLIANT Mean value (Unit) 13.03 103.33 49.93 51.77 Standard Deviation (Unit) 12.79 7.62 0.19 0.16 Standard Error (Unit) 0.41 0.25 0.01 0.01 Area under curve (Unit*sec.) 774.99 6143.45 2968.93 3078.16 40 MIN CELLIANT Mean value (Unit) 12.19 104.22 52.59 54.61 Standard Deviation (Unit) 2.28 10.22 0.45 0.51 Standard Error (Unit) 0.07 0.31 0.01 0.02 Area under curve (Unit*sec.) 797.03 6816.43 3439.7 3571.91 50 MIN CELLIANT Mean value (Unit) 13.19 108.65 53.26 55.23 Standard Deviation (Unit) 2.2 10.52 0.29 0.29 Standard Error (Unit) 0.07 0.33 0.01 0.01 Area under curve (Unit*sec.) 836.74 6891.66 3378.19 3503.05 60 MIN CELLIANT Mean value (Unit) 14.97 107.18 55.44 58.77 Standard Deviation (Unit) 3.1 10.43 0.32 0.22 Standard Error (Unit) 0.09 0.32 0.01 0.01 Area under curve (Unit*sec.) 1010.21 7234.09 3742.32 3967.38 10 MIN PLACEBO Mean value (Unit) 21.3 100.68 58.51 62 Standard Deviation (Unit) 4.84 33.08 0.29 0.51 Standard Error (Unit) 0.15 1.05 0.01 0.02 Area under curve (Unit*sec.) 1308.59 6185.51 3595.11 3809.65 20 MIN PLACEBO Mean value (Unit) 21.82 110.34 57.2 59.93 Standard Deviation (Unit) 4.03 22.22 0.3 0.3 Standard Error (Unit) 0.13 0.69 0.01 0.01 Area under curve (Unit*sec.) 1383.84 6998.02 3627.8 3801.03

30 MIN PLACEBO Mean value (Unit) 24.02 119.21 57.44 59.5 Standard Deviation (Unit) 4.86 29.74 0.22 0.28 Standard Error (Unit) 0.16 0.96 0.01 0.01 Area under curve (Unit*sec.) 1427.97 7087.93 3415.21 3537.56 40 MIN PLACEBO Mean value (Unit) 26.29 102.83 57.06 59.07 Standard Deviation (Unit) 5.46 17.63 0.23 0.25 Standard Error (Unit) 0.17 0.54 0.01 0.01 Area under curve (Unit*sec.) 1719.79 6726.44 3732.44 3863.84 50 MIN PLACEBO Mean value (Unit) 24.5 112.79 56.39 58.63 Standard Deviation (Unit) 5.63 38.24 0.25 0.41 Standard Error (Unit) 0.18 1.21 0.01 0.01 Area under curve (Unit*sec.) 1506.26 6934.67 3466.66 3604.71 60 MIN PLACEBO Mean value (Unit) 25.4 94.83 58.13 60.06 Standard Deviation (Unit) 5.18 23.13 0.48 0.6 Standard Error (Unit) 0.15 0.68 0.01 0.02 Area under curve (Unit*sec.) 1816.98 6780.63 4158.57 4296.31

Patient ID:116 placebo - Celliant BASELINE TCOM HAND LASER HAND TCOM FOOT LASER FOOT Mean value (Unit) 7.41 8.01 87.64 3.96 Standard Deviation (Unit) 6.55 0.79 0.44 0.19 Standard Error (Unit) 0.16 0.02 0.01 0 Area under curve (Unit*sec.) 764.23 825.69 9036.03 408.23 GENERAL CALCULATIONS : AREA 2 Mean value (Unit) 6.4 27.82 83 7.83 Standard Deviation (Unit) 7.08 13.25 1.09 0.21 Standard Error (Unit) 0.25 0.46 0.04 0.01 Area under curve (Unit*sec.) 323.81 1406.45 4193.85 395.74 GENERAL CALCULATIONS : AREA 3 Mean value (Unit) 10.5 35.26 80.84 8.39 Standard Deviation (Unit) 17.81 5.49 0.4 0.38 Standard Error (Unit) 0.63 0.19 0.01 0.01 Area under curve (Unit*sec.) 515.83 1731.63 3969.49 412.08 GENERAL CALCULATIONS : AREA 4 Mean value (Unit) 5.47 28.88 78.47 6.85 Standard Deviation (Unit) 0.7 12.07 0.27 1.34 Standard Error (Unit) 0.02 0.42 0.01 0.05 Area under curve (Unit*sec.) 279.74 1476.97 4013.99 350.46 GENERAL CALCULATIONS : AREA 5 Mean value (Unit) 6.3 21.09 85.28 3.87 Standard Deviation (Unit) 0.48 13.81 1.99 0.57 Standard Error (Unit) 0.02 0.48 0.07 0.02 Area under curve (Unit*sec.) 321.65 1077.17 4356.58 197.95 GENERAL CALCULATIONS : AREA 6 Mean value (Unit) 6.13 29.34 77.64 6.47 Standard Deviation (Unit) 0.96 10.12 0.35 0.71 Standard Error (Unit) 0.03 0.36 0.01 0.03 Area under curve (Unit*sec.) 291.96 1397.47 3696.87 308.07 GENERAL CALCULATIONS : AREA 7 Mean value (Unit) 6.2 40.39 85.05 2.62 Standard Deviation (Unit) 3.4 32.59 1.12 0.11 Standard Error (Unit) 0.12 1.17 0.04 0 Area under curve (Unit*sec.) 296.25 1927.41 4060.2 124.92 Mean value (Unit) 5.65 36.77 77.14 4.02 Standard Deviation (Unit) 0.47 16.61 0.93 0.12 Standard Error (Unit) 0.02 0.75 0.04 0.01 Area under curve (Unit*sec.) 172.76 1123.05 2358.01 122.96 GENERAL CALCULATIONS : AREA 9 Mean value (Unit) 5.84 55.19 80.92 4.04

Standard Deviation (Unit) 0.85 19.91 0.55 0.73 Standard Error (Unit) 0.02 0.45 0.01 0.02 Area under curve (Unit*sec.) 695.29 6574.94 9637.78 481.01 GENERAL CALCULATIONS : AREA 10 Mean value (Unit) 6.23 65.39 90.3 4.12 Standard Deviation (Unit) 2.01 50.18 0.41 0.45 Standard Error (Unit) 0.07 1.75 0.01 0.02 Area under curve (Unit*sec.) 318.79 3345.68 4618.86 210.69 GENERAL CALCULATIONS : AREA 11 Mean value (Unit) 6.05 40.51 93.24 3.9 Standard Deviation (Unit) 0.79 17.22 0.16 0.33 Standard Error (Unit) 0.03 0.61 0.01 0.01 Area under curve (Unit*sec.) 297.11 1989.82 4578.62 191.71 GENERAL CALCULATIONS : AREA 12 Mean value (Unit) 6.1 25.81 98.14 6.4 Standard Deviation (Unit) 1.02 22.14 0.25 0.48 Standard Error (Unit) 0.04 0.77 0.01 0.02 Area under curve (Unit*sec.) 311.99 1321.22 5019.89 327.57 GENERAL CALCULATIONS : AREA 13 Mean value (Unit) 5.98 30.97 94.84 6.38 Standard Deviation (Unit) 0.95 20.91 0.48 0.24 Standard Error (Unit) 0.03 0.73 0.02 0.01 Area under curve (Unit*sec.) 305.18 1580.65 4839.29 325.37 GENERAL CALCULATIONS : AREA 14 Mean value (Unit) 6.11 33.9 92.84 4.68 Standard Deviation (Unit) 0.67 11.63 1.54 0.35 Standard Error (Unit) 0.02 0.4 0.05 0.01 Area under curve (Unit*sec.) 312.45 1733.61 4748.48 239.43

Patient ID:117 Celliant - placebo BASELINE TCOM HAND LASER HAND TCOM FOOT LASER FOOT Mean value (Unit) 16.44 56.95 52.26 11.02 Standard Deviation (Unit) 2.73 5.94 0.32 0.08 Standard Error (Unit) 0.13 0.28 0.02 0 Area under curve (Unit*sec.) 449.51 1557.22 1428.92 301.3 10 MIN CELLIANT Mean value (Unit) 28.09 57.14 45.32 8.1 Standard Deviation (Unit) 2.3 5.74 0.1 0.12 Standard Error (Unit) 0.1 0.26 0 0.01 Area under curve (Unit*sec.) 879.4 1789.04 1418.89 253.64 20 MIN CELLIANT Mean value (Unit) 32.55 62.1 45.13 6.71 Standard Deviation (Unit) 2.98 10.82 0.13 0.01 Standard Error (Unit) 0.12 0.45 0.01 0 Area under curve (Unit*sec.) 1168.61 2229.22 1620.09 241.01 30 MIN CELLIANT Mean value (Unit) 31.87 63.74 44.1 7.75 Standard Deviation (Unit) 2.61 6.48 0.14 0 Standard Error (Unit) 0.12 0.29 0.01 0 Area under curve (Unit*sec.) 983.99 1968.15 1361.57 239.33 40 MIN CELLIANT Mean value (Unit) 31.84 59.1 42.44 5.46 Standard Deviation (Unit) 2.28 6.92 0.06 0.16 Standard Error (Unit) 0.1 0.3 0 0.01 Area under curve (Unit*sec.) 1026.69 1905.51 1368.12 176.01 50 MIN CELLIANT Mean value (Unit) 24.35 68.6 43.17 3.88 Standard Deviation (Unit) 1.3 4.9 0.44 0.12 Standard Error (Unit) 0.06 0.21 0.02 0.01 Area under curve (Unit*sec.) 795.71 2241.93 1410.59 126.72 60 MIN CELLIANT Mean value (Unit) 28.58 77.73 43.03 4.14 Standard Deviation (Unit) 3.11 4.23 0.32 0.14 Standard Error (Unit) 0.14 0.18 0.01 0.01 Area under curve (Unit*sec.) 934.08 2539.68 1405.82 135.37 10 MIN PLACEBO Mean value (Unit) 26.63 67.56 39.01 5.79 Standard Deviation (Unit) 1.2 90.84 0.39 0.12 Standard Error (Unit) 0.06 4.33 0.02 0.01 Area under curve (Unit*sec.) 726.47 1845.6 1064.31 157.92 20 MIN PLACEBO Mean value (Unit) 29.83 26.3 39.28 5.85 Standard Deviation (Unit) 1.74 2.51 0.12 0.19 Standard Error (Unit) 0.07 0.1 0 0.01 Area under curve (Unit*sec.) 1083.71 955.64 1427.11 212.48

30 MIN PLACEBO Mean value (Unit) 23.12 34.13 41.55 1.77 Standard Deviation (Unit) 2.09 7.75 0.5 0.11 Standard Error (Unit) 0.09 0.33 0.02 0 Area under curve (Unit*sec.) 789.82 1165.97 1419.51 60.42 40 MIN PLACEBO Mean value (Unit) 12.47 22.62 42.59 2.24 Standard Deviation (Unit) 2.26 2.81 0.32 0.1 Standard Error (Unit) 0.1 0.13 0.01 0 Area under curve (Unit*sec.) 368.78 668.97 1259.43 66.17 50 MIN PLACEBO Mean value (Unit) 11.83 22.53 44.05 2.84 Standard Deviation (Unit) 5.63 2.79 0.7 0.12 Standard Error (Unit) 0.23 0.11 0.03 0 Area under curve (Unit*sec.) 440.22 838.4 1638.59 105.76 60 MIN PLACEBO Mean value (Unit) 10.76 25.18 42.46 1.95 Standard Deviation (Unit) 1.46 1.86 0.22 0 Standard Error (Unit) 0.06 0.08 0.01 0 Area under curve (Unit*sec.) 380.94 891.19 1503.29 69.14

Patient ID:118 placebo - Celliant RECORDING INFORMATION BASELINE TCOM HAND LASER HAND TCOM FOOT LASER FOOT Mean value (Unit) 15.59 41.17 31.08 49.12 Standard Deviation (Unit) 1.53 6.23 1.44 1.37 Standard Error (Unit) 0.03 0.14 0.03 0.03 Area under curve (Unit*sec.) 1918.73 5067.54 3825.09 6045.28 10 MIN PLACEBO Mean value (Unit) 17.21 52.38 14.69 45.45 Standard Deviation (Unit) 1.45 4.66 0.96 0.47 Standard Error (Unit) 0.03 0.09 0.02 0.01 Area under curve (Unit*sec.) 2596.41 7900.42 2216.16 6855.66 20 MIN PLACEBO Mean value (Unit) 16.38 48.01 11.81 47.41 Standard Deviation (Unit) 1.49 10.4 0.77 0.74 Standard Error (Unit) 0.03 0.19 0.01 0.01 Area under curve (Unit*sec.) 2991.91 8767.94 2155.54 8657.17 30 MIN PLACEBO Mean value (Unit) 24.19 49.18 13.06 48.14 Standard Deviation (Unit) 29.59 9.07 0.79 0.3 Standard Error (Unit) 0.55 0.17 0.01 0.01 Area under curve (Unit*sec.) 4418.24 8979.26 2384.3 8789.47 40 MIN PLACEBO Mean value (Unit) 21.59 50.58 14.66 50.69 Standard Deviation (Unit) 17.23 8.07 1.27 0.38 Standard Error (Unit) 0.32 0.15 0.02 0.01 Area under curve (Unit*sec.) 3941.82 9234.92 2677.09 9255.53 50 MIN PLACEBO Mean value (Unit) 22.26 48.09 14.69 51.32 Standard Deviation (Unit) 9.22 11.02 1.23 0.77 Standard Error (Unit) 0.17 0.21 0.02 0.01 Area under curve (Unit*sec.) 3887.79 8400.42 2564.92 8963.13 60 MIN PLACEBO Mean value (Unit) 32.42 45.58 20.07 53.5 Standard Deviation (Unit) 41.87 11.34 0.85 0.67 Standard Error (Unit) 0.73 0.2 0.01 0.01 Area under curve (Unit*sec.) 6693.43 9409.93 4142.42 11043.63 10 MIN CELLIANT Mean value (Unit) 64.13 32.45 33.81 56.45 Standard Deviation (Unit) 64.22 19.46 1.25 1.88 Standard Error (Unit) 1.18 0.36 0.02 0.03 Area under curve (Unit*sec.) 11726.08 5933.78 6182.08 10322.27 20 MIN CELLIANT Mean value (Unit) 40.82 37.76 29.93 54.97 Standard Deviation (Unit) 3.67 9.1 1.88 0.75 Standard Error (Unit) 0.07 0.17 0.03 0.01

Area under curve (Unit*sec.) 7464.39 6904.57 5473.22 10050.86 30 MIN CELLIANT Mean value (Unit) 37.24 40.67 30.64 57.15 Standard Deviation (Unit) 3.53 9.68 1.01 0.45 Standard Error (Unit) 0.06 0.17 0.02 0.01 Area under curve (Unit*sec.) 7400.81 8084.58 6090.49 11358.87 40 MIN CELLIANT Mean value (Unit) 38.26 40.09 31.63 55.42 Standard Deviation (Unit) 7.69 7.08 1.44 0.69 Standard Error (Unit) 0.13 0.12 0.02 0.01 Area under curve (Unit*sec.) 7908.95 8286.38 6537.93 11454.59 50 MIN CELLIANT Mean value (Unit) 42.18 47.87 47.79 60.48 Standard Deviation (Unit) 4.38 4.97 3.93 2.58 Standard Error (Unit) 0.08 0.09 0.07 0.05 Area under curve (Unit*sec.) 8383.18 9514.03 9498.73 12020.27 60 MIN CELLIANT Mean value (Unit) 41.98 47.64 44.73 63.55 Standard Deviation (Unit) 4.23 4.51 1.47 1.12 Standard Error (Unit) 0.09 0.09 0.03 0.02 Area under curve (Unit*sec.) 6006.76 6815.94 6400.53 9092.94

Patient ID:119 placebo - Celliant BASELINE TCOM HAND LASER HAND TCOM FOOT LASER FOOT Mean value (Unit) 23.52 50.95 54.36 50.72 Standard Deviation (Unit) 2.67 21.02 1.12 0.64 Standard Error (Unit) 0.21 1.62 0.09 0.05 Area under curve (Unit*sec.) 243.36 528.2 562.72 525.14 10 MIN PLACEBO Mean value (Unit) 35.19 76.8 57.98 67.63 Standard Deviation (Unit) 12.13 29.13 0.29 0.29 Standard Error (Unit) 0.39 0.92 0.01 0.01 Area under curve (Unit*sec.) 2162.32 4714.42 3562.3 4155.21 20 MIN PLACEBO Mean value (Unit) 33.85 126.84 62.51 71.14 Standard Deviation (Unit) 15.21 114.56 1.14 1.61 Standard Error (Unit) 0.47 3.55 0.04 0.05 Area under curve (Unit*sec.) 2180.64 8174.5 4026.65 4582.78 30 MIN PLACEBO Mean value (Unit) 28.81 108.01 64.33 71.53 Standard Deviation (Unit) 9.77 54.75 0.52 0.81 Standard Error (Unit) 0.31 1.75 0.02 0.03 Area under curve (Unit*sec.) 1740.39 6528.88 3889.06 4323.97 40 MIN PLACEBO Mean value (Unit) 23.71 81.12 66.85 72.59 Standard Deviation (Unit) 6.25 22.46 0.93 0.97 Standard Error (Unit) 0.2 0.71 0.03 0.03 Area under curve (Unit*sec.) 1457.23 4984.26 4107.54 4460.26 50 MIN PLACEBO Mean value (Unit) 24.28 95.78 69.06 74.7 Standard Deviation (Unit) 7.34 15.73 0.26 0.24 Standard Error (Unit) 0.23 0.5 0.01 0.01 Area under curve (Unit*sec.) 1467.4 5790.62 4174.97 4515.4 60 MIN PLACEBO Mean value (Unit) 22.5 94.75 71.84 77 Standard Deviation (Unit) 4.97 24.66 0.72 0.72 Standard Error (Unit) 0.14 0.69 0.02 0.02 Area under curve (Unit*sec.) 1784.94 7516.97 5699.41 6108.26 10 MIN CELLIANT Mean value (Unit) 33.48 61.25 67.14 71.64 Standard Deviation (Unit) 11.29 18.59 0.64 0.5 Standard Error (Unit) 0.29 0.47 0.02 0.01 Area under curve (Unit*sec.) 3185.63 5829.21 6389.25 6817.88 20 MIN CELLIANT Mean value (Unit) 30.18 62.35 67.26 70.47 Standard Deviation (Unit) 5.45 30.2 0.91 1.13 Standard Error (Unit) 0.14 0.77 0.02 0.03 Area under curve (Unit*sec.) 2872.32 5934.04 6400.84 6706.8

30 MIN CELLIANT Mean value (Unit) 29.91 57.79 68.55 69.18 Standard Deviation (Unit) 6.75 33.9 1.78 1.21 Standard Error (Unit) 0.17 0.85 0.04 0.03 Area under curve (Unit*sec.) 2965.03 5729.62 6796.24 6858.19 40 MIN CELLIANT Mean value (Unit) 28.85 53.47 68.73 71.72 Standard Deviation (Unit) 5.15 18.13 0.69 0.66 Standard Error (Unit) 0.13 0.46 0.02 0.02 Area under curve (Unit*sec.) 2746.16 5088.82 6541.54 6825.3 50 MIN CELLIANT Mean value (Unit) 31.32 53.98 71.36 75.16 Standard Deviation (Unit) 6.79 16.96 1.66 1.59 Standard Error (Unit) 0.15 0.37 0.04 0.04 Area under curve (Unit*sec.) 3974.71 6850.74 9056.87 9539.52 60 MIN CELLIANT Mean value (Unit) 31.51 68.69 70.75 75.65 Standard Deviation (Unit) 5.98 50.86 1.25 1.4 Standard Error (Unit) 0.16 1.36 0.03 0.04 Area under curve (Unit*sec.) 2748.83 5993.38 6171.57 6599.18

Patient ID:120 Celliant - placebo BASELINE TCOM HAND LASER HAND TCOM FOOT LASER FOOT Mean value (Unit) 14.62 40.18 48.51 40.05 Standard Deviation (Unit) 7.77 7.89 0.77 1.08 Standard Error (Unit) 0.16 0.16 0.02 0.02 Area under curve (Unit*sec.) 2102.7 5779.24 6977.14 5760.26 10 MIN CELLIANT Mean value (Unit) 28.53 83.34 39.28 36.6 Standard Deviation (Unit) 9.34 68.95 2.18 0.93 Standard Error (Unit) 0.3 2.21 0.07 0.03 Area under curve (Unit*sec.) 1724.87 5038.3 2374.32 2212.52 20 MIN CELLIANT Mean value (Unit) 28.54 82.1 39.04 36.32 Standard Deviation (Unit) 9.1 67.49 2.08 1.13 Standard Error (Unit) 0.28 2.11 0.06 0.04 Area under curve (Unit*sec.) 1815.85 5224.97 2483.45 2310.99 30 MIN CELLIANT Mean value (Unit) 27.55 83.06 38.51 36.63 Standard Deviation (Unit) 9.97 19.27 0.95 0.75 Standard Error (Unit) 0.18 0.35 0.02 0.01 Area under curve (Unit*sec.) 5284.65 15934.12 7388.58 7027.39 40 MIN CELLIANT Item 1 PU #1 2 PU #2 3 pO2 #3 4 pO2 #4 Mean value (Unit) 27.13 84.15 34.32 36.2 Standard Deviation (Unit) 2.22 36.99 3.67 1.08 Standard Error (Unit) 0.07 1.13 0.11 0.03 Area under curve (Unit*sec.) 1801.68 5589.37 2278.5 2403.35 50 MIN CELLIANT Mean value (Unit) 27.7 65.54 42.87 40.44 Standard Deviation (Unit) 2 15.21 0.86 0.5 Standard Error (Unit) 0.06 0.48 0.03 0.02 Area under curve (Unit*sec.) 1729.84 4092.9 2676.46 2524.83 60 MIN CELLIANT Mean value (Unit) 24.58 60.17 47.49 41.93 Standard Deviation (Unit) 2.96 13.07 1.14 0.57 Standard Error (Unit) 0.09 0.42 0.04 0.02 Area under curve (Unit*sec.) 1510.02 3697.49 2918.27 2576.28 10 MIN PLACEBO Mean value (Unit) 24.48 64.62 50.15 51.08 Standard Deviation (Unit) 6.45 15.49 1.36 0.54 Standard Error (Unit) 0.13 0.32 0.03 0.01 Area under curve (Unit*sec.) 3501.99 9244.51 7174.09 7308.01 20 MIN PLACEBO Mean value (Unit) 37.31 70.95 47.86 48.42 Standard Deviation (Unit) 6.23 12.9 0.58 0.71 Standard Error (Unit) 0.16 0.33 0.01 0.02

Area under curve (Unit*sec.) 3557.69 6764.93 4564.05 4617.4 30 MIN PLACEBO Mean value (Unit) 28.94 71.24 50.17 51.49 Standard Deviation (Unit) 3.82 13.74 0.96 0.6 Standard Error (Unit) 0.12 0.44 0.03 0.02 Area under curve (Unit*sec.) 1720.64 4236.42 2983.25 3061.49 40 MIN PLACEBO Mean value (Unit) 21.87 90.2 48.61 50.33 Standard Deviation (Unit) 3.35 38.99 1.45 0.69 Standard Error (Unit) 0.09 0.99 0.04 0.02 Area under curve (Unit*sec.) 2085.7 8600.74 4635.14 4799.81 50 MIN PLACEBO Mean value (Unit) 22.24 106.75 45.99 49.16 Standard Deviation (Unit) 16.45 56.96 1.19 0.87 Standard Error (Unit) 0.39 1.34 0.03 0.02 Area under curve (Unit*sec.) 2475.36 11878.13 5116.7 5469.06 60 MIN PLACEBO Mean value (Unit) 27.65 79.06 52.92 53.02 Standard Deviation (Unit) 3.82 26.67 1.56 1.19 Standard Error (Unit) 0.09 0.65 0.04 0.03 Area under curve (Unit*sec.) 2850.9 8150.63 5456.89 5466.49



Mean value (Unit) 11.2 23.97 25.16 45.37 Standard Deviation (Unit) 0.62 6.12 0.46 0.6 Standard Error (Unit) 0.02 0.21 0.02 0.02 Area under curve (Unit*sec.) 575.41 1231.86 1293.08 2331.88 10 MIN PLACEBO Mean va

Celliant Blood Flow Studies · 2020. 9. 4. · Celliant Blood Flow Studies Objective: To evaluate...

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Transcript of Celliant Blood Flow Studies · 2020. 9. 4. · Celliant Blood Flow Studies Objective: To evaluate...